Drug Information

View drug alerts Information in California or New York
 
The Drug Information Center has a wealth of information to help you understand how drugs impact your health as well as their place in today's healthcare environment. 
 
The information you'll find in the center covers a number of important topics ranging from drug safety and side effects to medication costs and errors. You'll also notice from time to time we will display drug alerts. These alerts will let you know when a New Drug is put on the market, if a drug has been recalled, and if a drug has a new indication or use. 
 
 
Drug Name Drug Reason Date
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with bortezomib, thalidomide and dexamethasone (VTd) as treatment for individuals newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Source: FDA website
Expanded Indication 09-26-19
Dysport
The Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA injection) to include the treatment of upper limb spasticity in individuals aged 2 years and older, excluding spasticity caused by cerebral palsy. Source: FDA website
Expanded Indication 09-26-19
Mavyret
The Food and Drug Administration (FDA) approved Mavyret® (glecaprevir/pibrentasvir tablets) for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve). Source: FDA website
Expanded Indication 09-26-19
Rituxan
The Food and Drug Administration (FDA) approved Rituxan® (rituximab injection) to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids. Source: FDA website
Expanded Indication 09-27-19
Crysvita
The Food and Drug Administration (FDA) approved Crysvita® (burosumab injection) to include treatment in pediatric individuals as young as 6 months with X-linked hypophosphatemia (XLH). Source: FDA website
Expanded Indication 10-01-19
Invokana
The Food and Drug Administration (FDA) approved Invokana® (canagliflozin tablets) to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine. Source: FDA website
New Indication 09-27-19
Jynneos
The Food and Drug Administration (FDA) approved Jynneos® (smallpox and monkeypox vaccine, live, non-replicating injection) for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. Source: FDA website
New Vaccine 09-24-19
Apotex
Apotex announced a voluntary recall of ranitidine tablets, brand and generic formulations, due to the potential for detection of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and Source: FDA website
Drug Recall 09-27-19
Sandoz
Sandoz announced a voluntary recall of ranitidine capsules due to the potential for detection of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated Source: FDA website
Drug Recall 09-24-19
Taltz
The Food and Drug Administration (FDA) approved Taltz® (ixekizumab injection) for the treatment of adults with active ankylosing spondylitis. Source: FDA website
New Indication 08-23-19
Nourianz
The Food and Drug Administration (FDA) approved NourianzTM (istradefylline tablets) as an add-on treatment to levodopa/carbidopa in adults with Parkinson's disease (PD) experiencing "off" episodes. Source: FDA website
New Drug 08-27-19
Rinvoq
The Food and Drug Administration (FDA) approved RinvoqTM (upadacitinib tablets) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Source: FDA website
New Drug 08-16-19
Xenleta
The Food and Drug Administration (FDA) approved XenletaTM (lefamulin tablets and injection) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. Source: FDA website
New Drug 08-19-19
AmEx Pharmacy
The Food and Drug Administration (FDA) is reminding consumers and healthcare providers not to use drug products intended to be sterile made by Pacifico National Inc., an outsourcing facility doing business as AmEx Pharmacy in Melbourne, Florida due to quality and sterility concerns. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/news-events/press-announcements/fda-requests-recall-sterile-compounded-drug-products-produced-pacifico-national-inc-dba-amex Source: FDA website
Drug Warning 08-27-19
Hepatitis C medications
The Food and Drug Administration (FDA) has received reports that the use of MavyretTM (glecaprevir/pibrentasvir tablets), Zepatier® (elbasvir/grazoprevir tablets), or Vosevi® (sofosbuvir/velpatasvir tablets) to treat chronic Hepatitis C in individuals with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/hepatitis-c-medicines-mavyret-zepatier-and-vosevi-drug-safety-communication-due-rare-occurrence-0 Source: FDA website
Drug Warning 08-28-19
Clenpiq
The Food and Drug Administration (FDA) approved Clenpiq® (sodium picosulfate/magnesium oxide/anhydrous citric acid oral solution) to include use in pediatric individuals 9 years of age and older for cleansing of the colon as a preparation for colonoscopy. Source: FDA website
Expanded Indication 08-12-19
Sirturo
The Food and Drug Administration (FDA) approved Sirturo® (bedaquiline tablets) use in pediatric individuals aged 12 to less than 18 years and weighing at least 30 kg as part of combination therapy for pulmonary multidrug-resistant tuberculosis (MDR-TB), when an effective treatment regimen cannot otherwise be provided. Source: FDA website
New Indication 08-12-19
Dulera
The Food and Drug Administration (FDA) approved Dulera® (mometasone furoate/formoterol fumarate oral inhaler) for asthma in pediatric individuals 5 years of age and older. Source: FDA website
Expanded Indication 08-14-19
Asmanex HFA
The Food and Drug Administration (FDA) approved Asmanex® HFA (mometasone furoate oral inhaler) for asthma in pediatric individuals 5 years of age and older. Source: FDA website
Expanded Indication 08-14-19
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept pre-filled injection) for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. Source: FDA website
New Formulation 08-13-19
Pretomanid
The Food and Drug Administration (FDA) approved Pretomanid tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. Source: FDA website
New Drug 08-14-19
Wakix
The Food and Drug Administration (FDA) approved Wakix® (pitolisant tablets) for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. Source: FDA website
New Drug 08-14-19
Rozlytrek
The Food and Drug Administration (FDA) approved RozlytrekTM (entrectinib capsules) for the treatment of adult and adolescent individuals whose cancers have the specific genetic defect neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for whom there are no effective treatments. It is also indicated for the treatment of adults with non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive and have spread to other parts of the body. Source: FDA website
New Drug 08-15-19
Inrebic
The Food and Drug Administration (FDA) approved Inrebic® (fedratinib capsules) for the treatment of adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). Source: FDA website
New Drug 08-16-19
Relpax
Pfizer announced a voluntary recall of 2 lots of Relpax 40 mg tablets due to potential microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-inc-issues-voluntary-nationwide-recall-2-lots-relpaxr-eletriptan-hydrobromide-40-mg-tablets Source: FDA website
Drug Recall 08-15-19
Entacapone
The Food and Drug Administration (FDA) announced they found no increased risk of prostate cancer with Parkinson’s disease medications, Comtan (entacapone) and Stalevo (entacapone/carbidopa/levodopa). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-review-finds-no-increased-risk-prostate-cancer-parkinsons-disease-medicines-containing Source: FDA website
Drug Warning 08-13-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed death-ligand 1 PD-L1 (combined positive score ≥10) as determined by a Food and Drug Administration (FDA)-approved test, with disease progression after 1 or more prior lines of systemic therapy. Source: FDA website
New Indication 07-19-19
Enstilar
The Food and Drug Administration (FDA) approved Enstilar® Foam (calcipotriene/betamethasone dipropionate topical foam) for the treatment of plaque psoriais in individuals 12 years and older. Source: FDA website
Expanded Indication 08-01-19
Taclonex
The Food and Drug Administration (FDA) approved Taclonex® Topical Suspension (calcipotriene/betamethasone dipropionate topical suspension) for the treatment of plaque psoriais in individuals 12 years and older. Source: FDA website
Expanded Indication 08-01-19
Baqsimi
The Food and Drug Administration (FDA) approved BaqsimiTM (glucagon nasal powder) for the treatment of severe hypoglycemia in individuals with diabetes 4 years of age and older. Source: FDA website
New Formulation 07-24-19
Angiomax RTU
The Food and Drug Administration (FDA) approved Angiomax RTU (bivalirudin injection) for use as an anticoagulant in individuals undergoing percutaneous coronary intervention (PCI), including those with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Source: FDA website
New Formulation 07-25-19
Accrufer
The Food and Drug Administration (FDA) approved AccruferTM (ferric maltol capsules) for the treatment of iron deficiency in adults. Source: FDA website
New Drug 07-25-19
Nubeqa
The Food and Drug Administration (FDA) approved NubeqaTM (darolutamide tablets) for the treatment of men with non-metastatic castration-resistant prostate cancer. Source: FDA website
New Drug 07-30-19
Turalio
The Food and Drug Administration (FDA) approved TuralioTM (pexidartinib capsules) for the treatment of adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe disease or functional limitations, and cannot be improved with surgery, Source: FDA website
New Drug 08-02-19
Jubilant Cadista Pharmaceuticals
Jubilant Cadista Pharmaceuticals announced a voluntary recall of one lot of drospirenone and ethinyl estradiol tablets due to out-of-specification dissolution results that could affect efficacy. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jubilant-cadista-pharmaceuticals-inc-issues-voluntary-nationwide-recall-drospirenone-and-ethinyl Source: FDA website
Drug Recall 07-24-19
Ridge Properties
Ridge Properties announced a voluntary recall of 4 lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and higher than labeled potency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ridge-properties-llc-dba-pain-relief-naturally-issues-voluntary-nationwide-recall-pre-tat-superior-0 Source: FDA website
Drug Recall 08-09-19
Xeljanz; Xeljanz XR
The Food and Drug Administration (FDA) approved new warnings about an increased risk of blood clots and death with the 10 mg twice daily dose of Xeljanz® and Xeljanz XR® (tofacitinib tablets and tofacitinib extended-release tablets), which are used in individuals with ulcerative colitis. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-due-increased-risk-blood-clots-and-death Source: FDA website
Drug Warning 07-26-19
Otezla
The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of oral ulcers in adults with Behcet's disease. Source: FDA website
New Indication 07-19-19
Drizalma Sprinkle
The Food and Drug Administration (FDA) approved Drizalma SprinkleTM (duloxetine delayed-release capsules) for the treatment of chronic musculoskeletal pain, generalized anxiety disorder, major depressive disorder, and pain associated with diabetic peripheral neuropathy. Source: FDA website
New Formulation 07-19-19
Zinc sulfate
The Food and Drug Administration (FDA) approved Zinc sulfate injection in adult and pediatric individuals as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Source: FDA website
New Formulation 07-18-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all prescription and over-the-counter (OTC) drug products and lots, within expiry, sold by OCuSOFT during specific time period due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-ocusoft Source: FDA website
Drug Recall 07-16-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all over-the-counter (OTC) drug products and lots, within expiry, sold by Natural Ophthalmics and TRP Company, Inc. during specific time period due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-over-counter-ophthalmic-products-sold-natural Source: FDA website
Drug Recall 07-16-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all over-the-counter (OTC) drug products and lots, within expiry, sold by Accutome, Focus Laboratories, Grandall Distributing Co., and Prestige Brands during specific time period due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-over-counter-ophthalmic-products-sold Source: FDA website
Drug Recall 07-16-19
Kogenate FS Antihemophilic Factor
Bayer announced a voluntary recall of two lots of labeled Kogenate® FS antihemophilic factor (recombinant injection) 2000 IU vials due to these lots actually containing Jivi antihemophilic factor. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-statement-voluntary-recall-two-lots-kogenater-fs-antihemophilic-factor-recombinant-united Source: FDA website
Drug Recall 07-22-19
Xembify
The Food and Drug Administration (FDA) approved Xembify® (immune globulin subcutaneous, human injection) for the treatment of primary humoral immunodeficiency (PI) in individuals 2 years of age and older. Source: FDA website
New Formulation 07-03-19
Katerzia
The Food and Drug Administration (FDA) approved KaterziaTM (amlodipine benzoate oral suspension) for the treatment of hypertension (high blood pressure) in adults and pediatric individuals 6 years of age and older and coronary artery disease in adults. Source: FDA website
New Formulation 07-08-19
AirDuo Digihaler
The Food and Drug Administration (FDA) approved AirDuo® DigihalerTM (fluticasone propionate/salmeterol oral inhalation) with built-in electronic module, approved for the treatment of asthma in individuals aged 12 years and older. Source: FDA website
New Formulation 07-15-19
Recarbrio
The Food and Drug Administration (FDA) approved RecarbrioTM (imipenem/cilastatin/relebactam injection) to treat adults with complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs). Source: FDA website
New Drug 07-17-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced another voluntary recall of all over the counter (OTC) and prescription drug ophthalmic products and lots, within expiry, during specific time periods due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-manufactured-and Source: FDA website
Drug Recall 07-15-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all drug products and lots, within expiry, sold at Walgreens during a specified time period due to concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-walgreens Source: FDA website
Drug Recall 07-03-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all drug products and lots, within expiry, sold at CVS during a specified time period due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-cvs Source: FDA website
Drug Recall 07-10-19
Thiola EC
The Food and Drug Administration (FDA) approved Thiola® EC (tiopronin enteric-coated tablets) for the treatment of cystinuria. Source: FDA website
New Formulation 06-28-19
Xpovio
The Food and Drug Administration (FDA) approved XpovioTM (selinexor tablets) indicated in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody. Source: FDA website
New Drug 07-03-19
Fresenius Kabi
Fresenius Kabi announced a voluntary recall of 2 lots of fluorouracil injection due to the potential for glass particulate. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-two-lots-fluorouracil-injection-due-potential Source: FDA website
Drug Recall 07-02-19
PharMEDium Services
PharMEDium Services announced a voluntary recall of 45 lots of hydromorphone injection due to their electronic customer ordering system stating the products are sulfite-free when they do contain sulfite. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedium-services-llc-issues-voluntary-nationwide-recall-05-mgml-hydromorphone-hcl-09-sodium Source: FDA website
Drug Recall 06-28-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all drug products and lots within expiry distributed during specific time periods due to possible sterility issues. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products Source: FDA website
Drug Recall 07-03-19
Pacifico National
The Food and Drug Administration (FDA) is warning consumers and healthcare providers not to use products intended to be sterile produced by Pacifico National, doing business as AmEx Pharmacy, due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-pacifico-national-inc-dba Source: FDA website
Drug Warning 06-28-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) as monotherapy for the treatment of individuals with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Source: FDA website
New Indication 06-18-19
Livalo
The Food and Drug Administration (FDA) approved Livalo® (pitavastatin tablets) for use in pediatric individuals aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (ApoB). Source: FDA website
New Indication 06-18-19
Biktarvy
The Food and Drug Administration (FDA) approved Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide tablets) to include treatment of both adult and pediatric individuals weighing at least 25 kg with human immunodeficiency virus (HIV)-1 who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Source: FDA website
New Indication 06-19-19
Dextenza
The Food and Drug Administration (FDA) approved Dextenza® (dexamethasone ocular insert) for the treatment of ocular inflammation following ophthalmic surgery. Source: FDA website
New Indication 06-21-19
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) for the treatment of upper limb spasticity in pediatric individuals 2-17 years of age. Source: FDA website
New Indication 06-21-19
Symdeko
The Food and Drug Administration (FDA) approved Symdeko® (tezacaftor/ivacaftor tablets) for the treatment of pediatric individuals ages 6 years and older with cystic fibrosis who have certain genetic mutations. Source: FDA website
New Indication 06-21-19
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). Source: FDA website
New Indication 06-26-19
Doptelet
The Food and Drug Administration (FDA) approved Doptelet® (avatrombopag tablets) to include the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Source: FDA website
New Indication 06-27-19
Soliris
The Food and Drug Administration (FDA) approved Soliris® (eculizumab injection) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Source: FDA website
New Indication 06-27-19
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with lenalidomide and dexamethasone for individuals with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Source: FDA website Source: FDA website
New Indication 06-27-19
Myxredlin
The Food and Drug Administration (FDA) approved Myxredlin (human insulin in sodium chloride injection) to improve glycemic control in adults and pediatric individuals with diabetes mellitus. Source: FDA website
New Formulation 06-20-19
Vyleesi
The Food and Drug Administration (FDA) approved VyleesiTM (bremelanotide injection) for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Source: FDA website
New Drug 06-21-19
Macleods
Macleods Pharmaceuticals announced a voluntary recall of 32 lots of losartan potassium tablets and losartan potassium/hydrochlorothiazide tablets due to detection of trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/macleods-pharmaceutical-limited-issues-voluntary-nationwide-consumer-level-recall-losartan-potassium Source: FDA website
Drug Recall 06-26-19
Premier Pharmacy Labs
Premier Pharmacy Labs announced a voluntary recall of all unexpired products, intended to be sterile, due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/premier-pharmacy-labs-issues-voluntary-nationwide-recall-all-unexpired-sterile-drug-product-lots-due Source: FDA website
Drug Recall 06-19-19
RXQ Compounding
RXQ Compounding announced a voluntary recall of all sterile human and animal products within expiry due to lack of sterility process assurance associated with the production of sterile products. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rxq-compounding-llc-issues-voluntary-nationwide-recall-all-sterile-products-within-expiry-and Source: FDA website
Drug Recall 06-19-19
Infusion Options
Infusion Options announced a voluntary recall of all lots of sterile products within expiry due to a lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/infusion-options-inc-issues-voluntary-nationwide-recall-all-lots-all-sterile-products-due-lack Source: FDA website
Drug Recall 06-20-19
Fecal microbiota for transplantation
The Food and Drug Administration (FDA) announced that bacterial infections caused by multi-drug resistant organisms (MDROs) have occurred due to transmission of a MDRO from use of investigational fecal microbiota for transplantation (FMT). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/fecal-microbiota-transplantation-safety-communication-risk-serious-adverse-reactions-due Source: FDA website
Drug Warning 06-14-19
Medtronic MiniMed insulin pumps
The Food and Drug Administration (FDA) is warning about potential cybersecurity risks with certain Medtronic MiniMedTM insulin pumps. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/safety-communications/certain-medtronic-minimed-insulin-pumps-have-potential-cybersecurity-risks-fda-safety-communication Source: FDA website
Drug Warning 06-27-19
Zerbaxa
The Food and Drug Administration (FDA) approved Zerbaxa® (ceftolozane/tazobactam injection) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in individuals 18 years and older. Source: FDA website
New Indication 06-03-19
Emgality
The Food and Drug Administration (FDA) approved Emgality® (galcanezumab-gnlm injection) for the treatment of episodic cluster headache in adults. Source: FDA website
New Indication 06-04-19
Emflaza
The Food and Drug Administration (FDA) approved Emflaza® (deflazacort tablets and oral suspension) to include individuals with Duchenne muscular dystrophy (DMD) who are between 2 and 5 years old. Source: FDA website
New Indication 06-07-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for first-line treatment of individuals with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma as monotherapy for individuals whose tumors express programmed death-ligand 1 (PD-L1) (combined positive score ≥1) or in combination with platinum and fluorouracil (FU) regardless of PD-L1 expression. Source: FDA website
New Indication 06-11-19
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) for two new methods of administration, an autoinjector and a pre-filled safety syringe, for patients and caregivers to administer once every four weeks after a healthcare professional decides it is appropriate. Nucala is approved for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis. Source: FDA website
New Dosage Forms and Administration 06-06-19
Polivy
The Food and Drug Administration (FDA) approved PolivyTM (polatuzumab vedotin-piiq) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, in combination with bendamustine and a rituximab product, after at least two prior therapies. Source: FDA website
New Drug 06-10-19
Teva Pharmaceuticals
Teva Pharmaceuticals announced an expanded voluntary recall of six lots of bulk losartan potassium 50 mg and 100 mg tablets due to the detection of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-expands-voluntary-nationwide-recall-losartan-potassium-50-mg-and-100-mg Source: FDA website
Drug Recall 06-11-19
Glutathione L-reduced powder
The Food and Drug Administration (FDA) warned compounders not to use glutathione L-reduced powder distributed by Letco Medical to compound steroid injectable drugs. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables Source: FDA website
Drug Warning 06-10-19
Jakafi
The Food and Drug Administration (FDA) approved Jakafi® (ruxolitinib tablets) for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in individuals aged 12 years and older. Source: FDA website
New Indication 05-24-19
Vraylar
The Food and Drug Administration (FDA) approved Vraylar® (cariprazine capsules) to treat depressive episodes of bipolar I disorder. Source: FDA website
New Indication 05-24-19
Revlimid
The Food and Drug Administration (FDA) approved Revlimid® (lenalidomide capsules) in combination with rituximab for the treatment of adults with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL). Source: FDA website
New Indication 05-28-19
Lyrica
The Food and Drug Administration (FDA) approved Lyrica® (pregabalin capsules and oral solution) as adjunctive therapy in the treatment of partial-onset seizures, to include pediatric individuals 1 month to less than 4 years of age. Source: FDA website
New Indication 05-23-19
Nayzilam
The Food and Drug Administration (FDA) approved Nayzilam® (midazolam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from usual seizure pattern in individuals with epilepsy 12 years of age and older. Source: FDA website
New Formulation 05-17-19
Slynd
The Food and Drug Administration (FDA) approved Slynd (drospirenone tablets) for the prevention of pregnancy. Source: FDA website
New Formulation 05-23-19
Zolgensma
The Food and Drug Administration (FDA) approved Zolgensma® (onasemnogene abeparvovec-xioi injection) for the treatment of pediatric individuals <2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Source: FDA website
New Biologic 05-24-19
Piqray
The Food and Drug Administration (FDA) approved Piqray® (alpelisib tablets) for use with fulvestrant to treat men and postmenopausal women with hormone receptor-positive human epidermal growth factor receptor 2-negative (HR+/HER2−) PIK3CA-mutated advanced or metastatic breast cancer with progression following an endocrine-based regimen. Source: FDA website
New Drug 05-24-19
Pharm D Solutions
Pharma D Solutions announced a voluntary recall of all sterile compounded drug products within expiry due to a potential lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharm-d-solutions-llc-issues-voluntary-nationwide-recall-all-sterile-compounded-drugs-due-potential-0 Source: FDA website
Drug Recall 05-24-19
Heritage Pharmaceuticals
Heritage Pharmaceuticals announced a voluntary recall of amikacin sulfate injection and prochlorperazine edisylate injection due to sterility test failure. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/heritage-pharmaceuticals-inc-issues-voluntary-nationwide-recall-amikacin-sulfate-injection-usp-1gm4 Source: FDA website
Drug Recall 05-28-19
Novis PR
Novis PR announced a voluntary recall of 5 lots of PECGEN® DMX liquid cough syrup due to incorrect dosage information on the label caused by a typographical error. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-issues-voluntary-nationwide-recall-pecgen-dmx-due-labeling-error Source: FDA website
Drug Recall 05-31-19
Bavencio
The Food and Drug Administration (FDA) approved Bavencio® (avelumab injection) in combination with Inlyta® (axitinib tablets) for individuals with advanced renal cell carcinoma. Source: FDA website
New Indication 05-14-19
Cyramza
The Food and Drug Administration (FDA) approved Cyramza® (ramucirumab injection) for the second-line treatment of individuals with hepatocellular carcinoma (HCC) who are alpha fetoprotein (AFP-High) (AFP ≥400 ng/mL). Source: FDA website
New Indication 05-13-19
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA injection) as a first-line treatment for blepharospasm in adults. Source: FDA website
New Indication 05-13-19
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept injection) to treat all stages of diabetic retinopathy (DR). Source: FDA website
New Indication 05-13-19
Venclexta
The Food and Drug Administration (FDA) approved Venclexta® (venetoclax tablets) in combination with Gazyva® (obinutuzumab injection) for the treatment of individuals with previously untreated chronic lymphocytic leukemia (CLL). Source: FDA website
New Indication 05-15-19
Fragmin
The Food and Drug Administration (FDA) approved Fragmin® (dalteparin sodium injection) for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric individuals 1 month of age and older. Source: FDA website
New Indication 05-16-19
Gattex
The Food and Drug Administration (FDA) approved Gattex® (teduglutide injection) for pediatric individuals 1 year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). Source: FDA website
New Indication 05-17-19
Promacta
Novartis announced a voluntary recall of 3 lots of Promacta® (eltrombopag) 12.5 mg oral suspension due to the risk of potential peanut flour contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-promactar-125-mg-oral-suspension-due-potential-peanut Source: FDA website
Drug Recall 05-13-19
Devices for diabetes management not authorized for sale in the United States
The Food and Drug Administration (FDA) is warning against the use of devices for diabetes management not authorized for sale in the United States. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/news-events/press-announcements/fda-warns-against-use-unauthorized-devices-diabetes-management Source: FDA website
Drug Warning 05-17-19
Kadcyla
The Food and Drug Administration (FDA) approved Kadcyla® (trastuzumab emtansine injection) for adjuvant (after surgery) treatment of people with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment. Source: FDA website
Expanded Indication 05-06-19
Sorilux
The Food and Drug Administration (FDA) approved Sorilux® (calcipotriene topical foam) for the treatment of plaque psoriasis of the scalp and body in pediatric individuals 12 years of age and older. Source: FDA website
Expanded Indication 05-10-19
Ruzurgi
The Food and Drug Administration (FDA) approved Ruzurgi (amifampridine tablets) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in individuals 6 to <17 years of age. Source: FDA website
New Formulation 05-06-19
Vyndaqel and Vyndamax
The Food and Drug Administration (FDA) approved Vyndaqel® (tafamidis meglumine capsules) and VyndamaxTM (tafamidis capsules) for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular (CV) mortality and CV-related hospitalization. Source: FDA website
New Drugs 05-03-19
Vivimed Life Sciences
Vivimed Life Sciences announced a voluntary recall of 19 lots of losartan potassium due to the detection of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vivimed-life-sciences-pvt-ltd-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-50-mg-and Source: FDA website
Drug Recall 05-03-19
Benlysta
The Food and Drug Administration (FDA) approved Benlysta® (belimumab injection) to include use in children aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are currently receiving standard therapy. Source: FDA website
Expanded Indication 04-26-19
Praluent
The Food and Drug Administration (FDA) approved Praluent® (alirocumab injection) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease. Praluent also approved alone or in combination with other lipid-lowering therapies to treat adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia, to reduce low-density lipoprotein (LDL) cholesterol. Source: FDA website
Expanded Indication 04-28-19
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor capsules and oral granules) to include treatment of cystic fibrosis in individuals 6 months of age and older who have 1 mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive based on clinical and/or in vitro assay data. Source: FDA website
Expanded Indication 04-30-19
Mavyret
The Food and Drug Administration (FDA) approved MavyretTM (glecaprevir/pibrentasvir tablets) to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Source: FDA website
Expanded Indication 04-30-19
Tibsovo
The Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablets) to include treatment of adults with newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation as detected by a Food and Drug Administration (FDA)-approved test who are 75 years old or older or who have comorbidities that preclude use of intensive induction chemotherapy. Source: FDA website
Expanded Indication 05-02-19
Qternmet XR
The Food and Drug Administration (FDA) approved Qternmet® XR (dapagliflozin/saxagliptin/metformin extended-release tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Source: FDA website
New Formulation 05-03-19
Dengvaxia
The Food and Drug Administration (FDA) approved Dengvaxia® (dengue tetravalent vaccine, live, subcutaneous injection) for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. Source: FDA website
New Vaccine 05-02-19
Bevacizumab
AmEx Pharmacy announced a voluntary recall of one lot of bevacizumab injection due to reported defective delivery system. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amex-pharmacy-issues-voluntary-nationwide-recall-one-lot-bevacizumab-125mg005ml-31-g-syringe-due Source: FDA website
Drug Recall 04-29-19
Teva Pharmaceuticals
Teva Pharmaceuticals announced a voluntary recall of six lots of losartan potassium tablets sold exclusively to Golden State Medical Supply due to the detection of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-and-100-mg Source: FDA website
Drug Recall 04-30-19
Ketorolac tromethamine
Sagent Pharmaceuticals announced a voluntary recall of one lot of ketorolac tromethamine injection due to possible microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-ketorolac-tromethamine-injection-usp Source: FDA website
Drug Recall 04-30-19
Mycophenolate mofetil
Endo International announced a voluntary recall of one lot of mycophenolate mofetil injection due to observation of a glass fragment after reconstitution. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-pharmaceutical-inc-issues-voluntary-nationwide-recall-one-lot-mycophenolate-mofetil-injection Source: FDA website
Drug Recall 05-01-19
Insomnia medications
The Food and Drug Administration (FDA) is warning that rare but serious injuries have happened with certain common prescription insomnia medications because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. Additional labeling will be required. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/news-events/press-announcements/fda-requires-stronger-warnings-about-rare-serious-incidents-related-certain-prescription-insomnia Source: FDA website
Drug Warning 04-30-19
Corlanor
The Food and Drug Administration (FDA) approved Corlanor® (ivabradine oral solution) for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric individuals aged 6 months and older who are in sinus rhythm with an elevated heart rate. Source: FDA website
Expanded Indication 04-22-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with Inlyta®(axitinib tablets) for the first-line treatment of individuals with advanced renal cell carcinoma (RCC). Source: FDA website
New Indication 04-22-19
Tranexamic acid in sodium chloride
The Food and Drug Administration (FDA) approved Tranexamic acid in sodium chloride injection in individuals with hemophilia for short-term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Source: FDA website
New Formulation 04-15-19
Duobrii
The Food and Drug Administration (FDA) approved DuobriiTM (halobetasol propionate/tazarotene lotion) for the treatment of plaque psoriasis in adults. Source: FDA website
New Formulation 04-25-19
Balversa
The Food and Drug Administration (FDA) approved BalversaTM (erdafitinib tablets) for the treatment of locally advanced or metastatic urothelial carcinoma, with a susceptible fibroblast growth factor receptor (FGFR) 3 or 2 genetic alteration, that has progressed during or after platinum-based chemotherapy. Source: FDA website
New Drug 04-12-19
Skyrizi
The Food and Drug Administration (FDA) approved SkyriziTM (risankizumab-rzaa injection) for the treatment of plaque psoriasis in adults. Source: FDA website
New Drug 04-23-19
Legacy Pharmaceutical Packaging
Legacy Pharmaceutical Packaging announced an expanded voluntary recall of 1 additional lot of losartan potassium tablets due to the detection of trace amounts of an unexpected impurity found in the active pharmaceutical ingredient manufactured by Hetero Labs Limited. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm636624.htm Source: FDA website
Drug Recall 04-25-19
Fentanyl transdermal system
Alvogen announced a voluntary recall of 2 lots of fentanyl transdermal system patches due to product mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-inc-issues-voluntary-nationwide-recall-fentanyl-transdermal-system-due-product-mislabeling Source: FDA website
Drug Recall 04-19-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals announced an expanded recall for 36 lots losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets due to the detection of trace amounts of an unexpected impurity found in the active pharmaceutical ingredient manufactured by Hetero Labs Limited. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm636296.htm Source: FDA website
Drug Recall 04-19-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for first-line treatment of individuals with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express programmed death-ligand 1 (PD-L1) (tumor proportion score ≥1%), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
Expanded Indication 04-11-19
Zykadia
"The Food and Drug Administration (FDA) approved Zykadia® (ceritinib tablets) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a Food and Drug Administration (FDA)-approved test. Source: FDA website
New Dosage Form 03-18-19
Welchol
The Food and Drug Administration (FDA) approved Welchol® (colesevelam hydrochloride chewable bar) as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia, to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), and to improve glycemic control in adults with type 2 diabetes mellitus. Source: FDA website
New Dosage Form 04-03-19
Dovato
The Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine tablets) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known resistance to the individual components. Source: FDA website
New Formulation 04-08-19
Evenity
The Food and Drug Administration (FDA) approved EvenityTM (romosozumab-aqqg injection) for the treatment of osteoporosis in postmenopausal women at high risk for fracture or individuals who have failed or are intolerant to other available osteoporosis therapies. Source: FDA website
New Drug 04-09-19
Test strips for at home use
The Food and Drug Administration (FDA) is warning that using pre-owned test strips or test strips not authorized for sale in the United States may lead to inaccurate test results, potentially cause infection, and should not be used. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm635262.htm Source: FDA website
Drug Warning 04-08-19
Opioid pain medications
The Food and Drug Administration (FDA) identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm Source: FDA website
Drug Warning 04-09-19
Cimzia
The Food and Drug Administration (FDA) approved Cimzia® (certolizumab pegol injection) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Source: FDA website
New Indication 03-28-19
Ibrance
The Food and Drug Administration (FDA) approved Ibrance® (palbociclib capsules) in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in males. Source: FDA website
New Indication 04-04-19
Jatenzo
The Food and Drug Administration (FDA) approved Jatenzo® (testosterone undecanoate capsules) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website
New Formulation 03-27-19
Avaclyr
The Food and Drug Administration (FDA) approved AvaclyrTM (acyclovir ophthalmic ointment) for the treatment of acute herpetic keratitis (dendritic ulcers) in individuals with herpes simplex (HSV-1 and HSV-2) virus. Source: FDA website
New Formulation 03-29-19
Asceniv
The Food and Drug Administration (FDA) approved AscenivTM (immune globulin intravenous injection) for the treatment of primary humoral immunodeficiency disease in adults and adolescents. Source: FDA website
New Formulation 04-02-19
Duaklir Pressair
The Food and Drug Administration (FDA) approved Duaklir® Pressair® (aclidinium bromide/formoterol fumarate oral inhalation) for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Source: FDA website
New Formulation 03-29-19
Zelnorm
The Food and Drug Administration (FDA) approved ZelnormTM (tegaserod tablets) for the treatment of irritable bowel syndrome with constipation (IBS-C) in women under 65 years of age. Zelnorm was originally approved for the treatment of IBS-C in women and was voluntarily withdrawn due to a potential safety signal. Reintroduction to the market for appropriate individuals comes after a complete safety review by the FDA. Source: FDA website
Reintroduction to Market 03-29-19
Mayzent
The Food and Drug Administration (FDA) approved Mayzent® (siponimod tablets) for the treatment of adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS). Source: FDA website
New Drug 03-26-19
Mavenclad
"The Food and Drug Administration (FDA) approved Mavenclad® (cladribine tablets) for the second-line treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Source: FDA website "
New Drug 03-29-19
Venclexta
The Food and Drug Administration (FDA) reviewed data from the BELLINI trial evaluating the use of Venclexta® (venetoclax tablets) in combination with bortezomib and dexamethasone in individuals with multiple myeloma. The interim trial results demonstrated an increased risk of death for individuals receiving Venclexta as compared to the control group. The FDA has required no new patients be enrolled. Those who are receiving clinical benefit can continue treatment in the trial after they reconsent. This statement does not apply to patients taking Venclexta for an approved indication. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm634120.htm Source: FDA website
Drug Warning 03-22-19
Avycaz
The Food and Drug Administration (FDA) approved Avycaz® (avibactam/ceftazidime injection) for pediatric individuals aged 3 months and greater for the treatment of complicated intra-abdominal infections (cIAI), used in combination with metronidazole, and for complicated urinary tract infections (cUTI), including pyelonephritis. Source: FDA website
Expanded Indication 03-18-19
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) in combination with carboplatin and etoposide for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC). Source: FDA website
New Indication 03-19-19
Sunosi
The Food and Drug Administration (FDA) approved SunosiTM (solriamfetol tablets) to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Source: FDA website
New Drug 03-20-19
Zulresso
The Food and Drug Administration (FDA) approved ZulressoTM (brexanolone injection) for the treatment of postpartum depression in adults. Source: FDA website
New Drug 03-19-19
Sodium bicarbonate
Hospira announced a voluntary recall of sodium bicarbonate 8.4% injection due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm633663.htm Source: FDA website
Drug Recall 03-18-19
Legacy Pharmaceutical Packaging
Legacy Pharmaceutical Packaging announced a voluntary recall of 43 repackaged lots of losartan tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm633664.htm and https://www.fda.gov/Safety/Recalls/ucm633671.htm Source: FDA website
Drug Recall 03-18-19
Levoleucovorin
Mylan announced a voluntary recall of two lots of levoleucovorin injection due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm633784.htm Source: FDA website
Drug Recall 03-18-19
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) in combination with Abraxane® (paclitaxel protein-bound injection) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express programmed death-ligand 1 (PD-L1), as determined by a FDA-approved test. Source: FDA website
New Indication 03-08-19
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for the treatment of individuals 12 to 17 years of age with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Source: FDA website
Expanded Indication 03-11-19
Rocklatan
The Food and Drug Administration (FDA) approved RocklatanTM (netarsudil/latanoprost ophthalmic solution) for the reduction of intraocular pressure in individuals with open-angle glaucoma or ocular hypertension. Source: FDA website
New Formulation 03-12-19
Spravato
The Food and Drug Administration (FDA) approved SpravatoTM (esketamine nasal spray) for the treatment of treatment-resistant depression (TRD) in adults in conjunction with an oral antidepressant. Source: FDA website
New Drug 03-05-19
American Health Packaging
American Health Packaging announced a voluntary recall of valsartan tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632924.htm Source: FDA website
Drug Recall 03-10-19
Stokes Healthcare
Stokes Healthcare announced a voluntary recall of one lot of pilocarpine 0.1% ophthalmic solution due to a high level of preservative. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm633445.htm Source: FDA website
Drug Recall 03-13-19
Osphena
The Food and Drug Administration (FDA) approved Osphena® (ospemifene tablets) for moderate to severe vaginal dryness due to menopause. Source: FDA website
New Indication 01-29-19
Alimta
The Food and Drug Administration (FDA) approved Alimta® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the first-line treatment of individuals with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. Source: FDA website
New Indication 01-31-19
Tosymra
The Food and Drug Administration (FDA) approved Tosymra (sumatriptan nasal spray) for the acute treatment of migraine with or without aura in adults. Source: FDA website
New Formulation 01-25-19
Tris Pharma
Tris Pharma updated a previous recall of Infants' Ibuprofen Concentrated Oral Suspension to include 3 additional lots of Ibuprofen Oral Suspension Drops due to potential higher concentrations of ibuprofen. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm627780.htm Source: FDA website
Drug Recall 01-30-19
Cabometyx
The Food and Drug Administration (FDA) approved Cabometyx® (cabozantinib tablets) for individuals with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Source: FDA website
New Indication 01-14-19
Docefrez
The Food and Drug Administration (FDA) approved Docefrez® (docetaxel injection) for combination use with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive breast cancer, combination use with cisplatin and fluorouracil for untreated advanced gastric adenocarcinoma including the gastroesophageal junction, and combination use with cisplatin and fluorouracil for induction treatment of locally advanced squamous cell carcinoma of the head and neck cancer. Source: FDA website
New Indication 01-08-19
Adacel
The Food and Drug Administration (FDA) approved Adacel® (tetanus toxoid/reduced diphtheria toxoid/acellular pertussis [Tdap] vaccine adsorbed injection) for expanded use to allow for repeat vaccination in individuals 10 to 64 years old 8 or more years after the first vaccination. Source: FDA website
New Indication 01-15-19
Elepsia XR
The Food and Drug Administration (FDA) approved ElepsiaTM XR (levetiracetam extended-release tablets) as adjunctive therapy in the treatment of partial onset seizures in individuals 12 years and older with epilepsy. Source: FDA website
New Formulation 12-20-18
Vecuronium bromide
Sun Pharmaceutical Industries announced a voluntary recall of vecuronium bromide for injection due to the presence of particulate matter identified as glass. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629328.htm Source: FDA website
Drug Recall 01-08-19
Lupin Pharmaceuticals
Lupin Pharmaceuticals announced a voluntary recall of ceftriaxone for injection 250 mg, 500 mg, 1 g, and 2 g due to the presence of grey particulate matter in reconstituted vials. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629298.htm Source: FDA website
Drug Recall 01-06-19
Promacta
The Food and Drug Administration (FDA) approved Promacta® (eltrombopag tablets) as first-line treatment for adults and children 2 years and older with severe aplastic anemia (SAA) in combination with standard immunosuppressive therapy (IST). Source: FDA website
New Indication 11-16-18
Venclexta
The Food and Drug Administration (FDA) approved Venclexta® (venetoclax tablets) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in individuals aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to comorbidities. It is intended for use in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine (LDAC). Source: FDA website
New Indication 11-21-18
Aemcolo
The Food and Drug Administration (FDA) approved AemcoloTM (rifamycin delayed-release tablets) for the treatment of adults with travelers' diarrhea caused by non-invasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. Source: FDA website
New Formulation 11-16-18
Actemra ACTPen
The Food and Drug Administration (FDA) approved Actemra® ACTPen (tocilizumab prefilled autoinjector) for adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more disease-modifying anti-rheumatic drugs (DMARDs), and for adults with giant cell arteritis (GCA). In addition, for individuals aged 2 and older with polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), ACTPen can be administered by caregivers; the autoinjector has not been tested for self-injection in pediatrics. Source: FDA website
New Formulation 11-26-18
Temixys
The Food and Drug Administration (FDA) approved Temixys (lamivudine/tenofovir disoproxil fumarate tablets) for use in combination with other antiretrovirals for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric individuals weighing at least 35 kg. Source: FDA website
New Formulation 11-16-18
Gamifant
The Food and Drug Administration (FDA) approved Gamifant® (emapalumab injection) for the treatment of pediatric (newborn and older) and adult individuals with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Source: FDA website
New Drug 11-20-18
Daurismo
The Food and Drug Administration (FDA) approved DaurismoTM (glasdegib tablets) for the first-line treatment of acute myeloid leukemia (AML) in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy. Source: FDA website
New Drug 11-21-18
Vitrakvi
The Food and Drug Administration (FDA) approved Vitrakvi® (larotrectinib capsules and oral solution) for the treatment of individuals with solid tumors that have neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Source: FDA website
New Drug 11-26-18
Xospata
The Food and Drug Administration (FDA) approved Xospata® (gilteritinib tablets) for the treatment of adults who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Source: FDA website
New Drug 11-28-18
Firdapse
The Food and Drug Administration (FDA) approved Firdapse® (amifampridine tablets) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. Source: FDA website
New Drug 11-28-18
Sodium chloride
Fresenius Kabi announced a voluntary recall of sodium chloride injection by Fresenius Kabi due to product labeling incorrectly stating stoppers do not contain latex. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm626450.htm Source: FDA website
Drug Recall 11-23-18
Valsartan-containing products by Mylan
Mylan announces a voluntary recall of 15 lots of valsartan tablets, amlodipine/valsartan tablets, and valsartan/hydrochlorothiazide tablets due to the detection of trace amounts of an impurity found in active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm626367.htm Source: FDA website
Drug Recall 11-21-18
Valsartan-containing products by Teva
Teva announced a voluntary recall of all amlodipine/valsartan tablets and amlodipine/valsartan/hydrochlorothiazide tablets that are within expiry due to the detection of trace amounts of an impurity found in active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm626802.htm Source: FDA website
Drug Recall 11-27-18
ThermaCare HeatWraps by Pfizer
Pfizer Consumer Healthcare announced a voluntary recall of six lots of ThermaCare® HeatWrap due to the potential to leak ingredients that are contained in the heat cell wrap. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm626671.htm Source: FDA website
Drug Recall 11-26-18
Pharm D Solutions
The Food and Drug Administration (FDA) is alerting healthcare providers and consumers not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm626213.htm Source: FDA website
Drug Warning 11-19-18
Gilenya
The Food and Drug Administration (FDA) is warning that when the multiple sclerosis (MS) drug Gilenya® (fingolimod capsules) is stopped, the disease can become much worse than before the medication was started or while it was being taken. This MS worsening is rare but can result in permanent disability. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm626264.htm Source: FDA website
Drug Warning 11-20-18
Idhifa
The Food and Drug Administration (FDA) is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in individuals receiving the acute myeloid leukemia medicine Idhifa® (enasidenib tablets). The prescribing information and Medication Guide already contain a warning about differentiation syndrome. The agency is alerting health care providers and consumers about the need for early recognition and aggressive management of differentiation syndrome to lessen the likelihood of serious illness and death. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm626923.htm Source: FDA website
Drug Warning 11-29-18
Lemtrada
The Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in individuals with multiple sclerosis (MS) shortly after they received Lemtrada® (alemtuzumab injection). These problems can lead to permanent disability and death. A new warning has been added to the product labeling. Alemtuzumab is also approved under the brand name Campath® to treat B-cell chronic lymphocytic leukemia (B-CLL). The Campath drug label will also be updated. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm624247.htm Source: FDA website
Drug Warning 11-29-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Source: FDA website
New Indication 11-12-18
Oralair
The Food and Drug Administration (FDA) approved Oralair® (grass allergen extract sublingual tablet) for the treatment of grass pollen-induced allergic rhinitis in pediatric individuals aged 5-9 years. Source: FDA website
New Indication 11-14-18
Adcetris
The Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin injection) in combination with chemotherapy for adults with certain types of peripheral T-cell lymphoma (PTCL). Source: FDA website
New Indication 11-18-18
Yupelri
The Food and Drug Administration (FDA) approved YupelriTM (revefenacin oral inhalation) for the maintenance treatment of individuals with chronic obstructive pulmonary disease (COPD. Source: FDA website
New Drug 11-09-18
Implanted Pumps
The Food and Drug Administration (FDA) is aware that individuals undergoing treatment or management of pain are commonly given pain medicines via intrathecal administration that are not FDA approved for use with the implanted pump. The agency is recommending caution when selecting pain medicine for intrathecal administration. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm625862.htm Source: FDA website
Drug Warning 11-14-18
Hemlibra
The Food and Drug Administration (FDA) approved Hemlibra® (emicizumab injection) for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric individuals with hemophilia A with or without factor VIII inhibitors. Source: FDA website
New Indication 10-04-18
Gardasil 9
The Food and Drug Administration (FDA) approved Gardasil® 9 (human papillomavirus 9-valent vaccine injection) for vaccination in women and men aged 27 through 45 years. Source: FDA website
New Indication 10-05-18
Seysara
The Food and Drug Administration (FDA) approved SeysaraTM (sarecycline tablets) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in individuals 9 years and older. Source: FDA website
New Drug 10-02-18
Nuzyra
The Food and Drug Administration (FDA) approved NuzyraTM (omadacycline tablets and injection) for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections. Source: FDA website
New Drug 10-02-18
Tegsedi
The Food and Drug Administration (FDA) approved TegsediTM (inotersen injection) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Source: FDA website
New Drug 10-05-18
Revcovi
The Food and Drug Administration (FDA) approved RevcoviTM (elapegademase injection) for the treatment of adenosine deaminase severe combined immune deficiency. Source: FDA website
New Drug 10-05-18
Silver Star Brands
Silver Star Brands announced a voluntary recall of six products for humans and two for pets due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm622488.htm Source: FDA website
Drug Recall 10-03-18
Granix
The Food and Drug Administration (FDA) approved Granix® (tbo-filgrastim injection) to include reduction of duration of severe neutropenia in pediatric individuals 1 month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia. Source: FDA website
New Indication 08-07-18
Orkambi
The Food and Drug Administration (FDA) approved Orkambi® (lumacaftor/ivacaftor tablets and oral granules) to include use in children with cystic fibrosis (CF) ages two years through five years who have two copies of the F508del-CFTR mutation. Source: FDA website
New Indication 08-07-18
Signifor LAR
The Food and Drug Administration (FDA) approved Signifor® LAR (pasireotide pamoate injection) for the treatment of individuals with Cushing’s disease for whom pituitary surgery is not an option or has not been curative. Source: FDA website
New Indication 06-29-18
Jornay PM
The Food and Drug Administration (FDA) approved Jornay PMTM (methylphenidate extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years of age and older. Source: FDA website
New Formulation 08-09-18
Poteligeo
The Food and Drug Administration (FDA) approved Poteligeo® (mogamulizumab-kpkc injection) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. Source: FDA website
New Drug 08-08-18
Panzyga
The Food and Drug Administration (FDA) approved Panzyga® (immune globulin intravenous injection) for the treatment of primary humoral immunodeficiency in individuals 2 years of age and older and chronic immune thrombocytopenic purpura in adults. Source: FDA website
New Formulation 08-02-18
Arakoda
The Food and Drug Administration (FDA) approved ArakodaTM (tafenoquine tablets) for the prevention of malaria in people age 18 years old and older. Source: FDA website
New Drug 08-08-18
Annovera
The Food and Drug Administration (FDA) approved AnnoveraTM (segesterone acetate/ethinyl estradiol vaginal system) for the prevention of pregnancy. Source: FDA website
New Drug 08-10-18
Onpattro
The Food and Drug Administration (FDA) approved OnpattroTM (patisiran infusion) for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adults. Source: FDA website
New Drug 08-10-18
Galafold
The Food and Drug Administration (FDA) approved Galafold® (migalastat capsules) for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data. Source: FDA website
New Drug 08-10-18
Levothyroxine and Liothyronine
Westminster Pharmaceuticals announced a voluntary recall of all lots within expiration of levothyroxine and liothyronine tablets due to risk of adulteration. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls/ucm616601.htm Source: FDA website
Drug Recall 08-09-18
Product Quest Manufacturing
Product Quest Manufacturing announced a voluntary recall of one lot of CVS Health 12 Hour Sinus Relief Nasal Mist due to microbiological contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls/ucm616189.htm Source: FDA website
Drug Recall 08-08-18
Valsartan containing products
The Food and Drug Administration (FDA) updated the list of valsartan products under recall to include products manufactured by Hetero Labs Limited labeled as Camber Pharmaceuticals. Contact your healthcare provider with questions. More details and a list of affected products may be viewed at: https://www.fda.gov/drugs/drugsafety/ucm613916.htm Source: FDA website
Drug Recall 08-10-18
Dexycu
The Food and Drug Administration (FDA) approved Dexycu® (dexamethasone intraocular suspension injection) for the treatment of inflammation associated with cataract surgery. Source: FDA website
New Drug 02-12-18
Azedra
The Food and Drug Administration (FDA) approved Azedra® (iobenguane I 131 injection) for the treatment of individuals12 years old and older with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy. Source: FDA website
New Drug 07-30-18
Mulpleta
The Food and Drug Administration (FDA) approved Mulpleta® (lusutrombopag tablets) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Source: FDA website
New Drug 07-31-18
Zithromax, Zmax
The antibiotic Zithromax®, Zmax® (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in individuals with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these individuals. The Food and Drug Administration (FDA) are reviewing additional data and will communicate when their review is done. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm615738.htm Source: FDA website
Drug Warning 08-03-18
Piperacillin and tazobactam
AuroMedics Pharma announced a voluntary recall on piperacillin and tazobactam for injection 3.375 grams per vial due to the presence of particulates identified as glass and silicone material. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls/ucm615383.htm Source: FDA website
Drug Recall 01-08-18
Vonvendi
The Food and Drug Administration (FDA) approved Vonvendi® (von Willebrand factor, recombinant, injection) for the treatment of perioperative management of bleeding in adults with von Willebrand disease. Source: FDA website
New Indication 04-17-18
Tagrisso
The Food and Drug Administration (FDA) approved Tagrisso® (osimertinib tablets) for first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by a FDA-approved test. Source: FDA website
New Indication 04-18-18
Opdivo and Yervoy
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy® (ipilimumab injection) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. Source: FDA website
New Indication 04-16-18
Akynzeo
The Food and Drug Administration (FDA) approved Akynzeo® (fosnetupitant/palonosetron injection) for individuals with chemotherapy induced nausea and vomiting. Source: FDA website
New Formulation 04-20-18
Crysvita
The Food and Drug Administration (FDA) approved Crysvita® (burosumab-twza injection) for the treatment of X-linked hypophosphatemia (XLH) in adults and children 1 year of age and older. Source: FDA website
New Drug 04-17-18
Tavalisse
The Food and Drug Administration (FDA) approved TavalisseTM (fostamatinib disodium hexahydrate tablets) for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Source: FDA website
New Drug 04-17-18
Dexycu
The Food and Drug Administration (FDA) approved Dexycu® (dexamethasone intraocular suspension injection) for the treatment of inflammation associated with cataract surgery. Source: FDA website
New Drug 02-12-18
Imfinzi
The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection) for the treatment of individuals with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation. Source: FDA website
New Indication 02-16-18
Luzu
The Food and Drug Administration (FDA) approved Luzu® (luliconazole topical cream) for the treatment of tinea pedis, tinea cruris, and tinea corporis in individuals 12 years and older. Source: FDA website
New Indication 02-23-18
Verzenio
The Food and Drug Administration (FDA) approved Verzenio&tarde; (abemaciclib tablets) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer. Source: FDA website
New Indication 02-26-18
Otiprio
The Food and Drug Administration (FDA) approved Otiprio® (ciprofloxacin otic suspension) for the treatment of acute otitis externa (AOE) in patients 6 months old and older due to Pseudomonas aeruginosa and Staphylococcus aureus. Source: FDA website
New Indication 03-02-18
Osmolex ER
The Food and Drug Administration (FDA) approved Osmolex ER™ (amantadine extended-release tablets) for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adults. Source: FDA website
New Drug 02-19-18
Apadaz
The Food and Drug Administration (FDA) approved Apadaz™ (benzhydrocodone/acetaminophen tablets) for the short-term (14 or fewer days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Source: FDA website
New Drug 02-23-18
ZTlido
The Food and Drug Administration (FDA) approved ZTlido&tarde; (lidocaine topical system) for the relief of pain associated with post-herpetic neuralgia (PHN). Source: FA website
New Drug 02-28-18
Cimduo
The Food and Drug Administration (FDA) approved Cimduo&tarde; (lamivudine/tenofovir disoproxil fumarate tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric individuals weighing at least 35 kg. Source: FDA website
New Drug 02-28-18
Biaxin
The Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic Biaxin®(clarithromycin) to individuals with heart disease due to a potential increased risk of heart problems or death that can occur years later. A new warning has been added to the label. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm597862.htm Source: FDA website
Drug Warning 02-22-18
Symdeko
The Food and Drug Administration (FDA) approved SymdekoTM (tezacaftor/ivacaftor) for the treatment of individuals with cystic fibrosis (CF) who are at least 12 years old and who are either homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. Source: FDA website
New Drug 02-12-18
Erleada
The Food and Drug Administration (FDA) approved ErleadaTM (apalutamide tablets) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC). Source: FDA website
New Drug 02-14-18
Acyclovir
Apace Packaging announced a voluntary recall of one lot of acyclovir 400 mg tablets due to product mix-up. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm596590.htm Source: FDA website
Drug Recall 02-14-18
Clopidogrel
International Laboratories announced a voluntary recall of one lot of clopidogrel tablets 75 mg due to mislabeling. Contact your health care provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592047.htm Source: FDA website
Drug Recall 01-10-18
Balcoltra
The Food and Drug Administration (FDA) approved BalcoltraTM (levonorgestrel/ethinyl estradiol/ferrous bisglycinate tablets) for the prevention of pregnancy. Source: FDA website
New Drug 01-17-18
Trisenox
The Food and Drug Administration (FDA) approved Trisenox® (arsenic trioxide injection) in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. Source: FDA website
New Indication 01-15-18
Gilotrif
The Food and Drug Administration (FDA) approved Gilotrif® (afatinib tablets) in first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.Source: FDA website
New Indication 01-12-18
Fluarix Quadrivalent
The Food and Drug Administration (FDA) approved Fluarix® Quadrivalent (quadrivalent inactivated split virus influenza vaccine injection) to include use in individuals aged 6 months and older for active immunization against influenza A subtype viruses and type B viruses. Source: FDA website
New Indication 01-12-18
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the treatment of individuals with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. Source: FDA website
New Indication 01-12-18
Xgeva (denosumab)
The Food and Drug Administration (FDA) approved Xgeva® (denosumab injection) for the prevention of skeletal-related events in individuals with multiple myeloma. Source: FDA website
New Indication 01-05-18
Trulance
The Food and Drug Administration (FDA) approved Trulance® (plecanatide tablets) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Source: FDA website
New Indication 01-25-18
Zomacton
The Food and Drug Administration (FDA) approved Zomacton™ (somatropin injection) for the replacement of growth hormone (GH) in adults with GH deficiency. Source: FDA website
New Indication 02-01-18
Avycaz
The Food and Drug Administration (FDA) approved Avycaz® (ceftazidime/avibactam injection) to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in patients aged 18 years and older caused by susceptible Gram-negative microorganisms. Source: FDA website
New Indication 02-01-18
Firvanq
The Food and Drug Administration (FDA) approved Firvanq™ (vancomycin oral solution) for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. Source: FDA website
New Drug 01-29-18
Lutathera
The Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate injection), a radiopharmaceutical, for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) affecting the foregut, midgut, and hindgut. Source: FDA website
New Drug 01-26-18
Gericare Eye Wash
Kareway announced a voluntary recall of 60,000 lots of Gericare Eye Wash sterile eye irrigation solution due to the potential for product contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm595090.htm Source: FDA website
Drug Recall 02-02-18
Senna Laxative
Magno-Humphries Laboratories announced a recall of one lot of Basic Drugs brand of senna laxative tablets 8.6 mg due to mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm593201.htm Source: FDA website
Drug Recall 01-23-18
Imodium
The Food and Drug Administration (FDA) is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package for Imodium® (loperamide) over-the-counter (OTC) anti-diarrhea drug. The goal is to encourage safe use. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm594403.htm Source: FDA website
Drug Warning 01-30-18
Feraheme
The Food and Drug Administration (FDA) approved Feraheme® (ferumoxytol injection) expanded use to include all eligible adults with iron deficiency anemia who have intolerance to oral iron or have had unsatisfactory response to oral iron. Source: FDA website
New Indication 02-05-18
Zytiga
The Food and Drug Administration (FDA) approved Zytiga® (abiraterone acetate tablets) for use in combination with prednisone for the treatment of individuals with metastatic high-risk castration-sensitive prostate cancer (CSPC). Source: FDA website
New Indication 02-08-18
HyperRAB
The Food and Drug Administration (FDA) approved HyperRAB® (rabies immune globulin injection) for rabies post-exposure prophylaxis. This new formulation has a higher potency than existing product. Source: FDA website
New Drug 02-06-18
Biktarvy
The Food and Drug Administration (FDA) approved Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in adults who are treatment naïve or experienced. Source: FDA website
New Drug 02-07-18
Symfi Lo
The Food and Drug Administration (FDA) approved Symfi Lo™ (efavirenz/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric individuals weighing 35 kg or greater. Source: FDA website
New Drug 02-05-18
Latuda
The Food and Drug Administration (FDA) approved Latuda® (lurasidone tablets) for the treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in pediatric individuals aged 10 to 17 years. Source: FDA website
New Indication 03-07-18
Hizentra
The Food and Drug Administration (FDA) approved Hizentra® (immune globulin, human, 20% subcutaneous injection) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. Source: FDA website
New Indication 03-16-18
Trogarzo
The Food and Drug Administration (FDA) approved Trogarzo™ (ibalizumab-uiyk injection for intravenous use) for combination treatment of human immunodeficiency virus (HIV-1) infection in heavily treatment-experienced adults with multi-drug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen. Source: FDA website
New Drug 03-06-18
Adcetris
The Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin injection) in combination with chemotherapy in adults with previously untreated Stage III or IV classical Hodgkin lymphoma. Source: FDA website
New Indication 03-20-18
Tasigna
The Food and Drug Administration (FDA) approved Tasigna® (nilotinib capsules) for use in first and second line pediatric individuals 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. Source: FDA website
New Indication 03-22-18
Toujeo Max SoloStar
The Food and Drug Administration (FDA) approved Toujeo® Max SoloStar® (insulin glargine 300 Units/mL) to improve glycemic control in adults with diabetes mellitus. Source: FDA website
New Formulation 03-27-18
Ilumya
The Food and Drug Administration (FDA) approved Ilumya™ (tildrakizumab-asmn injection) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
New Drug 03-21-18
Alka-Seltzer Plus Products
Bayer announced a voluntary recall of selected Alka-Seltzer Plus® packages due to ingredients on front sticker possibly not matching product in carton. Please contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm601463.htm Source: FDA website
Drug Recall 03-16-18
Blincyto
The Food and Drug Administration (FDA) approved Blincyto® (blinatumomab injection) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD), Source: FDA website
New Indication 03-29-18
Leukine
The Food and Drug Administration (FDA) approved Leukine® (sargramostim injection) to increase survival in children and adults exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome (H-ARS). Source: FDA website
New Indication 03-30-18
Bydureon
The Food and Drug Administration (FDA) approved Bydureon® (exenatide extended-release injection) as an add-on to basal insulin in adults with type 2 diabetes who have inadequate glycemic control. Source: FDA website
New Indication 04-03-18
Rubraca
The Food and Drug Administration (FDA) approved Rubraca® (rucaparib tablets) as maintenance treatment for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Source: FDA website
New Indication 04-06-18
Afinitor Disperz
The Food and Drug Administration (FDA) approved Afinitor Disperz® (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric individuals 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Source: FDA website
New Indication 04-10-18
Symfi (efavirenz/lamivudine/tenofovir disoproxil fumarate)
The Food and Drug Administration (FDA) approved Symfi™ (efavirenz/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 in adults and children weighing 40 kg or more. Symfi contains the same ingredients found in Symfi Lo but with a 600 mg dose of efavirenz versus 400 mg seen in Symfi Lo. Source: FDA website
New Formulation 03-28-18
Essure
The Food and Drug Administration (FDA) restricted sales of the Essure® permanent birth control system to only doctors and healthcare facilities who use the FDA-approved "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement". New labeling was also approved. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm604126.htm Source: FDA website
Drug Warning 04-09-18
Trelegy Ellipta
The Food and Drug Administration (FDA) approved Trelegy Ellipta for long-term, once-daily, maintenance treatment of airflow obstruction in individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Indication 04-24-18
Jynarque
The Food and Drug Administration (FDA) approved Jynarque™ (tolvaptan tablets) to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Source: FDA website
New Drug 04-23-18
Lamictal
The Food and Drug Administration (FDA) warns that Lamictal® (lamotrigine) for seizures and bipolar disorder may cause a severe immune system reaction. A new warning will be added to the label. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm605628.htm Source: FDA website
Drug Warning 04-25-18
Mekinist and Tafinlar
The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) in combination for the adjuvant treatment of individuals with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Source: FDA website
New Indication 04-30-18
Mekinist and Tafinlar
The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) in combination for the treatment of anaplastic thyroid cancer (ATC) that is BRAF V600E mutation positive and either cannot be surgically excised or is metastatic. Source: FDA website
New Indication 05-04-18
Myrbetriq
The Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) in combination with solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Source: FDA website
New Indication 04-30-18
Kymriah
The Food and Drug Administration (FDA) approved Kymriah™ (tisagenlecleucel injection) for the treatment of adults with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Source: FDA website
New Indication 05-01-18
Andexxa
The Food and Drug Administration (FDA) approved Andexxa® (coagulation factor Xa [recombinant] inactivated-zhzo) to reverse the anticoagulation effects of factor Xa inhibitors when needed due to life-threatening or uncontrolled bleeding. Source: FDA website
New Drug 05-04-18
Lyrica
The Food and Drug Administration (FDA) approved Lyrica® (pregabalin capsules and oral solution) as adjunctive therapy for the treatment of partial onset seizures in individuals as young as 4 years old. Source: FDA website
New Indication 05-07-18
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination Velcade (bortezomib), melphalan, and prednisone for the treatment of individuals with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Source: FDA website
New Indication 05-07-18
Gilenya
The Food and Drug Administration (FDA) approved Gilenya® (fingolimod capsules) for the treatment of children and adolescents with relapsing multiple sclerosis (MS) who are aged 10 years or older. Source: FDA website
New Indication 05-11-18
Plenvu
The Food and Drug Administration (FDA) approved Plenvu® (polyethylene glycol 3350/sodium ascorbate/sodium sulfate/ascorbic acid/sodium chloride/potassium chloride for oral solution) for cleansing of the colon in preparation for colonoscopy in adults. Source: FDA website
New Drug 05-07-18
Medline Remedy Essentials No-Rinse Cleansing Foam
The Food and Drug Administration (FDA) is advising healthcare providers and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam due to a multistate outbreak of infection caused by Burkholderia cepacia. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm607371.htm Source: FDA website
Drug Warning 05-10-18
Briviact
The Food and Drug Administration (FDA) approved Briviact® (brivaracetam tablets and oral solution) as monotherapy and adjunctive therapy in the treatment of partial-onset seizures in individuals 4 years of age and older. Source: FDA website
New Indication 05-14-18
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab subcutaneous injection) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in individuals aged 2 years and older, as monotherapy or in combination with methotrexate. Source: FDA website
New Indication 05-14-18
Truvada
The Food and Drug Administration (FDA) approved Truvada® (emtricitabine/tenofovir disoproxil fumarate tablets) in combination with safer sex practices to reduce the risk of sexually acquired human immunodeficiency virus (HIV)-1 infection in at-risk adolescents. Source: FDA website
New Indication 05-15-18
Lucemyra
The Food and Drug Administration (FDA) approved Lucemyra™ (lofexidine tablets) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. Source: FDA website
New Drug 05-16-18
Aimovig
The Food and Drug Administration (FDA) approved Aimovig™ (erenumab subcutaneous injection) for the prevention of migraines in adults. Source: FDA website
New Drug 05-17-18
Lokelma
The Food and Drug Administration (FDA) approved Lokelma™ (sodium zirconium cyclosilicate for oral suspension) for the treatment of adults with hyperkalemia. Source: FDA website
New Drug 05-18-18
Doptelet
The Food and Drug Administration (FDA) approved Doptelet® (avatrombopag tablets) for the treatment of thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Source: FDA website
New Drug 05-21-18
Dolutegravir
Serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608168.htm Source: FDA website
Drug Warning 05-18-18
MBI Distributing
MBI Distributing, Inc. announced a voluntary recall of all lots of unexpired homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir due to a lack of adequate controls during the manufacturing process. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608254.htm Source: FDA website
Drug Recall 05-21-18
Prolia
The Food and Drug Administration (FDA) approved Prolia® (denosumab injection) for the treatment of glucocorticoid-induced osteoporosis. Source: FDA website
New Indication 05-21-18
Arnuity Ellipta
The Food and Drug Administration (FDA) approved Arnuity® Ellipta® (fluticasone furoate oral inhalation) as once-daily asthma maintenance treatment for children as young as age 5 years. Source: FDA website
New Indication 05-22-18
Cimzia
The Food and Drug Administration (FDA) approved Cimzia® (certolizumab pegol injection) for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
New Indication 05-29-18
Xeljanz
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets) for the treatment of adults with moderately to severely active ulcerative colitis. Source: FDA website
New Indication 05-30-18
Yonsa
The Food and Drug Administration (FDA) approved Yonsa® (abiraterone acetate tablets) micronized formulation for the treatment of metastatic castration-resistant prostate cancer in combination with methylprednisolone. Source: FDA website
New Drug 05-23-18
Imvexxy
The Food and Drug Administration (FDA) approved Imvexxy™ (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia, or vaginal pain during sexual activity caused by vulvar and vaginal atrophy during menopause. Source: FDA website
New Drug 05-30-18
Consensi
The Food and Drug Administration (FDA) approved Consensi™ (amlodipine/celecoxib tablets) for individuals for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Source: FDA website
New Drug 05-31-18
Palynziq
The Food and Drug Administration (FDA) approved Palynziq™ (pegvaliase-pqpz) to reduce blood phenylalanine concentrations in adults with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations >600 micromol/L on existing management. Source: FDA website
New Drug 05-29-18
Olumiant
The Food and Drug Administration (FDA) approved Olumiant® (baricitinib tablets) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more tumor-necrosis factor (TNF) antagonists. Source: FDA website
New Drug 06-01-18
Benzocaine
The Food and Drug Administration (FDA) is warning that over-the-counter (OTC) oral products containing benzocaine should not be used to treat infants and children younger than 2 years. They are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label due to the risk of serious and potentially fatal blood disorder. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608612.htm Source: FDA website
Drug Warning 05-23-18
Ethyl alcohol
Lake Michigan Distilling Company, doing business as Ethanol Extraction, announced a recall of its 95% Ethyl alcohol product due to possible contamination with methanol. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608695.htm Source: FDA website
Drug Recall 05-24-18
Fluticasone propionate
Apotex announced a recall of fluticasone propionate nasal spray 50 mcg per spray due to the potential for small glass particles. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609488.htm Source: FDA website
Drug Recall 05-31-18
Taytulla
Allergan announced a recall of Taytulla™ (norethindrone acetate/ethinyl estradiol capsules and ferrous fumarate capsules) due to out of sequence capsules. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609064.htm Source: FDA website
Drug Recall 05-29-18
Alimta
The Food and Drug Administration (FDA) approved Alimta® (pemetrexed injection) in combination with carboplatin and Keytruda® (pembrolizumab injection) for the initial treatment of individuals with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. Source: FDA website
New Indication 06-05-18
Mircera
The Food and Drug Administration (FDA) approved Mircera® (methoxy polyethylene glycol-epoetin beta injection) for the treatment of pediatric individuals 5 to 17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA. Source: FDA website
New Indication 06-07-18
Rituxan
The Food and Drug Administration (FDA) approved Rituxan® (rituximab injection) for the treatment of moderate to severe pemphigus vulgaris. Source: FDA website
New Indication 06-08-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for individuals with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test. Source: FDA website
New Indication 06-12-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of adult and pediatric individuals with refractory primary mediastinal large B-cell lymphoma (PMBCL) or who have relapsed after two or more prior lines of therapy. Source: FDA website
New Indication 06-13-18
Venclexta
The Food and Drug Administration (FDA) approved Venclexta™ (venetoclax tablets) in combination with rituximab for the treatment of individuals with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Source: FDA website
New Indication 06-08-18
Avastin
The Food and Drug Administration (FDA) approved Avastin® (bevacizumab injection) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection. Source: FDA website
New Indication 06-13-18
Moxidectin
The Food and Drug Administration (FDA) approved Moxidectin tablets for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in individuals ages 12 years and older. Source: FDA website
New Drug 06-14-18
Guardian Pharmacy Services
At least 43 individuals reported adverse events after receiving eye injections of Guardian's Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. Adverse events reported included vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm610835.htm Source: FDA website
Drug Warning 06-14-18
Cinryze
The Food and Drug Administration (FDA) approved Cinryze® (C1 esterase inhibitor, human, injection) for the prevention of attacks in pediatric hereditary angioedema in individuals as young as 6 years. Source: FDA website
New Indication 06-21-18
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA injection) for the treatment of excessive drooling in adults. Source: FDA website
New Indication 07-05-18
Nocdurna
The Food and Drug Administration (FDA) approved Nocdurna® (desmopressin acetate sublingual tablet) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Source: FDA website
New Formulation 06-22-18
Qbrexza
The Food and Drug Administration (FDA) approved Qbrexza™ (glycopyrronium topical cloths) for the treatment of primary axillary hyperhidrosis in individuals ages 9 years and older. Source: FDA website
New Formulation 06-29-18
Aristada Initio
The Food and Drug Administration (FDA) approved Aristada Initio™ (aripiprazole lauroxil extended-release injectable suspension) in combination with oral aripiprazole for the initiation of Aristada in the treatment of adults with schizophrenia. Aristada Initio is not for repeated dosing. Source: FDA website
New Formulation 07-02-18
Epidiolex
The Food and Drug Administration (FDA) approved Epidiolex® (cannabidiol oral solution) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in individuals 2 years of age and older. Source: FDA website
New Drug 06-25-18
Zemdri
The Food and Drug Administration (FDA) approved Zemdri™ (plazomicin injection) for adults with complicated urinary tract infections including pyelonephritis, caused by certain Enterobacteriaceae in individuals who have limited or no alternative treatment options. Source: FDA website
New Drug 06-26-18
Braftovi and Mektovi
The Food and Drug Administration (FDA) approved Braftovi® (encorafenib) and Mektovi™ (binimetinib) in combination for individuals with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Source: FDA website
New Drug 06-27-18
Opdivo and Yervoy
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy (ipilimumab injection)® for the treatment of adult and pediatric individuals 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Source: FDA website
New Indication 07-11-18
Intelence
The Food and Drug Administration (FDA) approved Intelence® (etravirine tablets) for treatment-experienced pediatric individuals 2 to <6 years of age weighing 10 kg or more for the treatment of human immunodeficiency virus (HIV)-1 infection, in combination with other antiretrovirals. Source: FDA website
New Indication 07-18-18
Zomacton
The Food and Drug Administration (FDA) approved Zomacton® (somatropin for subcutaneous injection) for the treatment of pediatric individuals with idiopathic short stature (ISS), short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by 2–4 years, and short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency. Source: FDA website
New Indication 07-19-18
Xtandi
The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide capsules) for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Source: FDA website
New Indication 07-16-18
Kisqali
The Food and Drug Administration (FDA) approved Kisqali® (ribociclib tablets) in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Source: FDA website
New Indication 07-18-18
Perseris
The Food and Drug Administration (FDA) approved Perseris™ (risperidone extended-release subcutaneous injection) for once-monthly treatment of schizophrenia in adults. Source: FDA website
New Formulation 07-27-18
Symtuza
The Food and Drug Administration (FDA) approved Symtuza™ (darunavir/cobicistat/emtricitabine/tenofovir alafenamide tablets) for the treatment of adults with human immunodeficiency virus (HIV)-1 infection who are treatment-naïve or virologically suppressed on a stable antiretroviral regimen for 6 or more months with no known darunavir or tenofovir resistance substitutions. Source: FDA website
New Drug 07-18-18
Orilissa
The Food and Drug Administration (FDA) approved Orilissa™ (elagolix tablets) for the management of moderate to severe endometriosis-associated pain. Source: FDA website
New Drug 07-24-18
Krintafel
The Food and Drug Administration (FDA) approved Krintafel™ (tafenoquine tablets) for the prevention of relapse of Plasmodium vivax malaria in individuals aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. Source: FDA website
New Drug 07-23-18
TPOXX
The Food and Drug Administration (FDA) approved TPOXX® (tecovirimat capsules) for the treatment of human smallpox disease in adults and pediatric individuals weighing at least 13 kg. Source: FDA website
New Drug 07-16-18
Tibsovo
The Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablets) for the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a susceptible IDH1 mutation as detected by an FDA approved test. Source: FDA website
New Drug 07-20-18
Fluoroquinolone antibiotics
The Food and Drug Administration (FDA) is strengthening current warnings in the prescribing label that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm Source: FDA website
Drug Warning 07-10-18
Ranier's Compounding Laboratory
The Food and Drug Administration (FDA) is alerting health care providers and consumers not to use drug products intended to be sterile that are produced and distributed by Ranier's Compounding Laboratory due to lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/drugs/drugsafety/ucm612911.htm Source: FDA website
Drug Recall 07-10-18
Valsartan containing product
The Food and Drug Administration (FDA) announced a recall on valsartan products containing an impurity, N-nitrosodimethylamine (NDMA), a potentially cancer-causing substance. Contact your healthcare provider with any questions. More details including affected products may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm614030.htm Source: FDA website
Drug Recall 07-19-18
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) to include use in children aged at least 12 months but younger than 24 months who carry at least one responsive CFTR mutation. Source: FDA website
New Indication 08-15-18
Lenvima
The Food and Drug Administration (FDA) approved Lenvima® (lenvatinib capsules) for first-line treatment of individuals with unresectable hepatocellular carcinoma. Source: FDA website
New Indication 08-16-18
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with small cell lung cancer (SCLC) with disease progression following two or more lines of therapy. Source: FDA website
New Indication 08-16-18
Cequa
The Food and Drug Administration (FDA) approved Cequa™ (cyclosporine ophthalmic solution) to increase tear production in individuals with keratoconjunctivitis sicca (dry eye). Source: FDA website
New Drug 08-16-18
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib tablets and capsules) for combination use with rituximab for the treatment of adults with Waldenström's macroglobulinemia (WM). Source: FDA website
New Indication 08-27-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of individuals with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 08-20-18
Altreno
The Food and Drug Administration (FDA) approved Altreno™ (tretinoin lotion) for the treatment of acne vulgaris in individuals 9 years of age and older. Source: FDA website
New Formulation 08-24-18
Inveltys
The Food and Drug Administration (FDA) approved Inveltys™ (loteprednol etabonate ophthalmic suspension) for the treatment of post-operative inflammation and pain following ocular surgery. Source: FDA website
New Drug 08-23-18
Oxervate
The Food and Drug Administration (FDA) approved Oxervate™ (cenegermin ophthalmic solution) for the treatment of neurotrophic keratitis. Source: FDA website
New Drug 08-22-18
Takhzyro
The Food and Drug Administration (FDA) approved Takhzyro™ (lanadelumab-flyo injection) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in individuals 12 years and older. Source: FDA website
New Drug 08-23-18
Diacomit
The Food and Drug Administration (FDA) approved Diacomit® (stiripentol oral capsules and powder) for the treatment of seizures associated with Dravet syndrome in individuals 2 years of age and older taking clobazam. Source: FDA website
New Drug 08-23-18
Xerava
The Food and Drug Administration (FDA) approved Xerava™ (eravacycline injection) for the treatment of complicated intra-abdominal infections in individuals 18 years of age and older. Source: FDA website
New Drug 08-27-18
Torrent Pharmaceuticals
Torrent Pharmaceuticals Limited announced a voluntary recall of all lots of valsartan/amlodipine/HCTZ and valsartan tablets due to the detection of trace amounts of an unexpected impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm617821.htm Source: FDA website
Drug Recall 08-21-18
King Bio
King Bio announced a voluntary recall of its Kids and Infant products due to potential microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm617945.htm Source: FDA website
Drug Recall 08-22-18
Jivi
The Food and Drug Administration (FDA) approved Jivi® (antihemophilic factor, recombinant, PEGylated-aucl injection) approved for the treatment of hemophilia A. Source: FDA website
New Drug 08-30-18
Pifeltro
The Food and Drug Administration (FDA) approved Pifeltro™ (doravirine tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in adults with no prior antiretroviral treatment history. Source: FDA website
New Drug 08-30-18
Delstrigo
The Food and Drug Administration (FDA) approved Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate tablets) as a complete regimen for the treatment of human immunodeficiency virus (HIV)-1 infection in adults with no antiretroviral treatment history. Source: FDA website
New Drug 08-30-18
Sodium-glucose cotransporter-2 (SGLT2) inhibitors
The Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. A new warning about this risk will be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm618908.htm Source: FDA website
Drug Warning 08-29-18
Hydrochlorothiazide
Accord Healthcare announced a voluntary recall of one lot of hydrochlorothiazide tablets 12.5 mg due to a labeling mix-up. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618583.htm Source: FDA website
Drug Recall 08-28-18
Children's Advil
Pfizer announced a voluntary recall of one lot of Children's Advil® due to dosage cup mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618675.htm Source: FDA website
Drug Recall 08-28-18
Quest Manufacturing
Quest Manufacturing announced they are expanding their voluntary recall of CVS Health 12 Hour Sinus Relief Nasal Mist to include all lots of nasal products and baby oral gels within expiration that were manufactured at the company’s Florida facility due to possible microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618803.htm Source: FDA website
Drug Recall 08-29-18
Weight Away Remedy
Living Well Remedies announced a voluntary recall of one lot of Weight Away Remedy due to microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618669.htm Source: FDA website
Drug Recall 08-28-18
HelloLife
HelloLife, Inc. announced a voluntary recall of all lots within expiration of Neuroveen™, Respitrol™, Thyroveev™ and Compulsin™ due to possible microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618926.htm Source: FDA website
Drug Recall 08-31-18
Tiglutik
The Food and Drug Administration (FDA) approved Tiglutik™ (riluzole oral suspension) for the treatment of amyotrophic lateral sclerosis (ALS). Source: FDA website
New Formulation 09-06-18
Cassipa
The Food and Drug Administration (FDA) approved Cassipa (buprenorphine/naloxone sublingual film) for the maintenance treatment of opioid dependence. Source: FDA website
New Formulation 09-07-18
Montelukast sodium
The Food and Drug Administration (FDA) is warning about a voluntary recall of one lot of montelukast sodium tablets by Camber Pharmaceuticals due to incorrect drug in bottles. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm619825.htm Source: FDA website
Drug Recall 08-31-18
Beaumont Bio Med
Beaumont Bio Med announced a voluntary recall of all unexpired aqueous/alcohol-based products due to possible microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm619587.htm Source: FDA website
Drug Recall 09-05-18
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). Source: FDA website
New Indication 10-11-18
Liletta
The Food and Drug Administration (FDA) approved Liletta® (levonorgestrel-releasing intrauterine system) to prevent pregnancy for up to 5 years. Source: FDA website
New Indication 10-16-18
Stiolto Respimat
The Food and Drug Administration (FDA) approved Stiolto® Respimat® (tiotropium bromide/olodaterol oral inhalation) for long-term, once-daily maintenance treatment of individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Indication 10-11-18
Yutiq
The Food and Drug Administration (FDA) approved YutiqTM (fluocinolone acetonide intravitreal implant) for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye. Source: FDA website
New Drug 10-15-18
Talzenna
The Food and Drug Administration (FDA) approved TalzennaTM (talazoparib capsules) for individuals with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer based on an FDA-approved companion diagnostic. Source: FDA website
New Drug 10-16-18
Sprayology
Sprayology announced a voluntary recall of all lots within expiry from 10/18-07/22 of its aqueous-based homeopathic product line for human use due to possible microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm622919.htm Source: FDA website
Drug Recall 10-11-18
Actemra SC
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab subcutaneous injection) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) alone or in combination with methotrexate in individuals 2 years of age or older. Source: FDA website
New Indication 09-13-18
Xelpros
The Food and Drug Administration (FDA) approved Xelpros™ (latanoprost ophthalmic emulsion) for the reduction of elevated intraocular pressure (IOP) in individuals with open-angle glaucoma or ocular hypertension. Source: FDA website
New Formulation 09-14-18
Lumoxiti
The Food and Drug Administration (FDA) approved Lumoxiti™ (moxetumomab pasudotox injection) for adults with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies including treatment with a purine nucleoside analog (PNA). Source: FDA website
New Drug 09-13-18
Years to Your Health
The Food and Drug Administration (FDA) is alerting consumers not to use any products made by Years to Your Health of Irving, Texas due to risk for serious infection. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm620564.htm Source: FDA website
Drug Warning 09-14-18
Furosemide
SCA Pharmaceuticals announced a voluntary recall of 7 lots of the injectable product furosemide 100 mg in 0.9% sodium chloride 100 mg bag due to visible particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm619776.htm Source: FDA website
Drug Recall 09-06-18
Pharm D Solutions
Pharm D Solutions announced a voluntary recall of all sterile compounded drugs due to a potential lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm620054.htm Source: FDA website
Drug Recall 09-11-18
Coagadex
The Food and Drug Administration (FDA) approved Coagadex® (coagulation factor X, human, injection) in adults and children for routine prophylaxis to prevent or reduce the frequency of bleeding episodes and for perioperative management of bleeding to include individuals with moderate hereditary Factor X deficiency. Source: FDA website
New Indication 09-26-18
Fycompa
The Food and Drug Administration (FDA) approved Fycompa® (perampanel tablets and oral suspension) in pediatric individuals as young as 4 years old for the treatment of partial-onset seizures. Source: FDA website
New Indication 09-28-18
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection) prefilled syringe formulation for the treatment of allergic asthma and chronic idiopathic urticaria. Source: FDA website
New Formulation 10-01-18
Xyosted
The Food and Drug Administration (FDA) approved Xyosted™ (testosterone auto-injection) for once weekly testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website
New Formulation 10-01-18
Symjepi
The Food and Drug Administration (FDA) approved Symjepi™ (epinephrine injection) 0.15 mg dose to treat anaphylaxis in pediatric individuals who weigh between 33 and 65 pounds. Source: FDA website
New Formulation 09-28-18
Arikayce
The Food and Drug Administration (FDA) approved Arikayce® (amikacin liposome oral inhalation suspension) for the treatment of Mycobacterium avium complex (MAC) in individuals who do not respond to conventional treatment. Source: FDA website
New Drug 09-28-18
Ajovy
The Food and Drug Administration (FDA) approved Ajovy™ (fremanezumab injection) for the prevention of chronic and episodic migraine headaches in adults. Source: FDA website
New Drug 09-17-18
Copiktra
The Food and Drug Administration (FDA) approved Copiktra™ (duvelisib capsules) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after 2 or more prior therapies and relapsed or refractory follicular lymphoma (FL) after 2 or more prior therapies. Source: FDA website
New Drug 09-14-18
Vizimpro
The Food and Drug Administration (FDA) approved Vizimpro® (dacomitinib tablets) for first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Source: FDA website
New Drug 09-27-18
Emgality
The Food and Drug Administration (FDA) approved Emgality™ (galcanezumab injection) for the prevention of chronic and episodic migraine headaches in adults. Source: FDA website
New Drug 09-27-18
Libtayo
The Food and Drug Administration (FDA) approved Libtayo® (cemiplimab injection) for the treatment of individuals with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Source: FDA website
New Drug 09-28-18
Zhejiang Huahai Pharmaceuticals
The Food and Drug Administration (FDA) placed Zhejiang Huahai Pharmaceuticals on import alert while the active pharmaceutical ingredient (API) manufacturer determines how impurities were introduced into its valsartan products. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/drugs/drugsafety/ucm613916.htm Source: FDA website
Drug Warning 09-28-18
Pen Needles
The Food and Drug Administration (FDA) is providing recommendations to promote the safe use of pen needles used to inject medications from pen injectors. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm621788.htm Source: FDA website
Drug Warning 09-27-18
Biolyte Laboratories
BioLyte Laboratories announced a voluntary recall of certain lots of NeoRelief, a homeopathic topical gel for muscle cramping and restlessness, due to possible microbial contamination. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm620481.htm Source: FDA website
Drug Recall 09-12-18
Robaxin
Endo International announced a voluntary recall of 2 lots of Robaxin 750 mg tablets 100 count bottle packs due to incorrect daily dosing information on label. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm622008.htm Source: FDA website
Drug Recall 09-28-18
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of hidradenitis suppurativa in adolescents. Source: FDA website
New Indication 10-16-18
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) as an add-on maintenance therapy in individuals with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Source: FDA website
New Indication 10-19-18
Afluria, Afluria Quadrivalent
The Food and Drug Administration (FDA) approved Afluria® (trivalent, inactivated influenza vaccine injection) and Afluria® Quadrivalent (quadrivalent, inactivated influenza vaccine injection) for use in individuals 6 months and older. Both were previously indicated for individuals 5 years of age and older. Source: FDA website
New Indication 10-23-18
Xyrem
The Food and Drug Administration (FDA) approved Xyrem® (sodium oxybate oral solution) for the treatment of cataplexy and excessive daytime sleepiness (EDS) in pediatric individuals ages 7 to 17 years old with narcolepsy. Source: FDA website
New Indication 10-26-18
Invokana
The Food and Drug Administration (FDA) approved Invokana® (canagliflozin tablets) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes who have established CV disease. Source: FDA website
New Indication 10-30-18
Invokamet, Invokamet XR
The Food and Drug Administration (FDA) approved Invokamet® (canagliflozin/metformin tablets) and Invokamet® XR (canagliflozin/metformin extended-release tablets) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes who have established CV disease. Source: FDA website
New Indication 10-30-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with carboplatin and either paclitaxel or nab-paclitaxel for first-line treatment of squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression. Source: FDA website
New Indication 10-30-18
Sympazan
The Food and Drug Administration (FDA) approved Sympazan™ (clobazam oral film) as adjunct treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in individuals aged 2 years and older. Source: FDA website
New Formulation 11-05-18
Qmiiz ODT
The Food and Drug Administration (FDA) approved Qmiiz ODT™ (meloxicam orally disintegrating tablets) for the treatment of osteoarthritis, rheumatoid arthritis, and juvenile idiopathic arthritis. Source: FDA website
New Formulation 10-19-18
Egrifta
The Food and Drug Administration (FDA) approved Egrifta™ (tesamorelin injection) single-vial formulation for the treatment of excess abdominal visceral adipose tissue (VAT) in human immunodeficiency virus (HIV)-infected individuals with lipodystrophy. Source: FDA website
New Formulation 11-05-18
Khapzory
The Food and Drug Administration (FDA) approved Khapzory™ (levoleucovorin injection) for rescue after high-dose methotrexate therapy in individuals with osteosarcoma, diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination, and the treatment of individuals with metastatic colorectal cancer in combination with fluorouracil. Source: FDA website
New Formulation 10-23-18
Bijuva
The Food and Drug Administration (FDA) approved Bijuva (estradiol/progesterone capsules) for the treatment of moderate to severe vasomotor symptoms due to menopause in women who have a uterus. Source: FDA website
New Formulation 10-29-18
Dsuvia
The Food and Drug Administration (FDA) approved Dsuvia (sufentanil sublingual tablets) for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. It is not intended for use beyond 72 hours. Source: FDA website
New Formulation 11-02-18
Lorbrena
The Food and Drug Administration (FDA) approved Lorbrena® (lorlatinib tablets) for individuals with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. Source: FDA website
New Drug 11-02-18
Xofluza
The Food and Drug Administration (FDA) approved Xofluza™ (baloxavir marboxil tablets) for the treatment of acute uncomplicated influenza in individuals 12 years of age and older who have been symptomatic for no more than 48 hours. Source: FDA website
New Drug 10-24-18
EpiPen
The Food and Drug Administration (FDA) is alerting consumers and healthcare providers that the labels attached to some EpiPen® (epinephrine 0.3mg auto-injectors) and EpiPen Jr® (epinephrine 0.15mg auto-injectors), and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product. Contact your healthcare provider with any questions. More details may be viewed at: https://www.drugs.com/fda_alerts.html Source: FDA website
Drug Warning 11-02-18
Genetic Tests
The Food and Drug Administration (FDA) warns against the use of many genetic tests with unapproved claims to predict patient response to specific medications. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm624725.htm Source: FDA website
Drug Warning 11-01-18
Aurobindo Pharma Limited
Aurobindo Pharma Limited announced a voluntary recall of 22 batches of irbesartan due to the presence of an impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm624547.htm Source: FDA website
Drug Recall 10-26-18
Sciegen Pharmaceuticals
Sciegen Pharmaceuticals announced a voluntary recall of certain lots of irbesartan tablets due to detection of an impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm624593.htm Source: FDA website
Drug Recall 10-30-18
Ortho-Novum 1/35 and Ortho-Novum 7/7/7
Janssen Pharmaceuticals announced a voluntary recall of one lot of Ortho-Novum® 1/35 (norethindrone/ethinyl estradiol tablets) and two lots of Ortho-Novum® 7/7/7 (norethindrone/ethinyl estradiol tablets) due to incorrect Veridate dispenser instructions. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm625012.htm Source: FDA website
Drug Recall 11-02-18
Promise Pharmacy
Promise Pharmacy announced a voluntary recall of one lot of prednisolone and gatifloxacin ophthalmic solution due to small particulate floating in the solution. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm623994.htm Source: FDA website
Drug Recall 10-22-18
Empliciti
The Food and Drug Administration (FDA) approved Empliciti® (elotuzumab injection) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Source: FDA website
New Indication 11-06-18
Bryhali
The Food and Drug Administration (FDA) approved Bryhali™ (halobetasol propionate topical lotion) for the treatment of plaque psoriasis in adults. Source: FDA website
New Formulation 11-07-18
Kadesh Incorporation
Kadesh, Inc. announced a voluntary recall of all lots of Puriton Eye Relief Drops due to non-sterile production conditions. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm625305.htm Source: FDA website
Drug Recall 11-07-18
Sandoz
Sandoz announced a voluntary recall of one lot of losartan potassium hydrochlorothiazide tablets 100mg/25mg due to the trace amount of an impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm625492.htm Source: FDA website
Drug Recall 11-09-18
Astagraf XL
The Food and Drug Administration (FDA) approved Astagraf XL® (tacrolimus extended-release capsules) for prophylaxis of organ rejection in kidney transplant in combination with other immunosuppressants in pediatric individuals 4 years of age and older. Source: FDA website
New Indication 11-29-18
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment, of individuals with metastatic non-squamous non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 12-06-18
Dextenza
The Food and Drug Administration (FDA) approved Dextenza® (dexamethasone ophthalmic insert) for the treatment of ocular pain after ophthalmic surgery. Source: FDA website
New Formulation 12-03-18
Valsartan-containing products from Mylan
Mylan announced an expansion of its voluntary recall to include all lots of valsartan-containing products within expiry due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm627647.htm Source: FDA website
Drug Recall 12-05-18
Tris Pharma
Tris Pharma announced a voluntary recall of 3 lots of Infants' Ibuprofen Concentrated Oral Suspension due to higher concentrations of ibuprofen. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm627780.htm Source: FDA website
Drug Recall 12-06-18
Viread
The Food and Drug Administration (FDA) approved Viread® (tenofovir disoproxil fumarate tablets) for use in chronic hepatitis B in individuals aged 2 to less 12 years old. Source: FDA website
New Indication 12-13-18
Nplate
The Food and Drug Administration (FDA) approved Nplate® (romiplostim injection) for pediatric individuals 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Source: FDA website
New Indication 12-14-18
Tolsura
The Food and Drug Administration (FDA) approved Tolsura™ (SUBA-itraconazole capsules) for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis), and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy). The new formulation is expected to have improved bioavailability. Source: FDA website
New Formulation 12-12-18
Promise Pharmacy
The Food and Drug Administration (FDA) alerted health care providers and consumers not to use drug products intended to be sterile from Promise Pharmacy due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm627929.htm Source: FDA website
Drug Recall 12-07-18
Oxtellar XR
The Food and Drug Administration (FDA) approved Oxtellar XR® (oxcarbazepine extended-release tablets) as a monotherapy for individuals age 6 and older who have partial-onset seizures. Source: FDA website
New Indication 12-14-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for adult and pediatric individuals with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Source: FDA website
New Indication 12-19-18
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Source: FDA website
New Indication 12-19-18
Envarsus XR
The Food and Drug Administration (FDA) approved Envarsus XR® (tacrolimus extended-release tablets) to prevent organ rejection in de novo kidney transplant individuals in combination with other immunosuppressants. Source: FDA website
New Indication 12-19-18
Motegrity
The Food and Drug Administration (FDA) approved Motegrity™ (prucalopride tablets) for the treatment of chronic idiopathic constipation (CIC) in adults. Source: FDA website
New Drug 12-14-18
Enovachem Pharmaceuticals
Enovachem Pharmaceuticals announced a voluntary recall of Dyural-40™ and Dyural-80™ (methylprednisolone acetate injection) Convenience Kits containing recalled sodium chloride injection due to latex hazard. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm628712.htm Source: FDA website
Drug Recall 12-18-18
Ravicti
The Food and Drug Administration (FDA) approved Ravicti® (glycerol phenylbutyrate oral liquid) for children under 2 months for the chronic management of urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Source: FDA website
New Indication 12-14-18
Sprycel
The Food and Drug Administration (FDA) approved Sprycel® (dasatinib tablets) for the treatment of pediatric individuals one year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy. Source: FDA website
New Indication 01-02-19
Licart
The Food and Drug Administration (FDA) approved Licart™ (diclofenac epolamine topical system) for the treatment of acute pain due to minor strains, sprains, and contusions. Source: FDA website
New Formulation 12-19-18
Vaxelis
The Food and Drug Administration (FDA) approved Vaxelis™ (diphtheria and tetanus toxoids/acellular pertussis adsorbed/inactivated poliovirus/haemophilus b conjugate [meningococcal protein conjugate]/hepatitis b [recombinant]) to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b for children from 6 weeks through 4 years of age. Source: FDA website
New Formulation 12-27-18
Inbrija
The Food and Drug Administration (FDA) approved Inbrija™ (levodopa inhalation powder) for the treatment of OFF periods in individuals with Parkinson’s disease taking carbidopa/levodopa. Source: FDA website
New Formulation 12-22-18
Asparlas
The Food and Drug Administration (FDA) approved Asparlas™ (calaspargase pegol-mknl injection) for the treatment of acute lymphoblastic leukemia (ALL) in individuals age 1 month to 21 years old. Source: FDA website
New Drug 12-20-18
Ultomiris
The Food and Drug Administration (FDA) approved Ultomiris™ (ravulizumab-cwvz injection) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Source: FDA website
New Drug 12-21-18
Elzonris
The Food and Drug Administration (FDA) approved Elzonris™ (tagraxofusp-erzs) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in individuals 2 years of age or older. Source: FDA website
New Drug 12-21-18
Aurobindo
Aurobindo announced a voluntary recall of 80 lots of amlodipine/valsartan tablets, valsartan/hydrochlorothiazide tablets, and valsartan tablets due to an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629213.htm Source: FDA website
Drug Recall 01-02-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals announced a voluntary recall of 2 lots of losartan potassium tablets due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm628966.htm Source: FDA website
Drug Recall 12-20-18
Torrent Pharmaceuticals
Torrent Pharmaceuticals is expanding its voluntary recall to include 8 additional lots of losartan potassium tablets due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/Safety/Recalls/ucm629261.htm Source: FDA website
Drug Recall 01-04-19
Fluoroquinolone antibiotics
A Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm628960.htm Source: FDA website
Drug Warning 12-20-18
Fluzone Quadrivalent
The Food and Drug Administration (FDA) approved Fluzone® Quadrivalent (influenza vaccine 0.5 mL injection) to include influenza vaccination of children age 6 through 35 months. Source: FDA website
New Indication 01-24-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals is expanding its voluntary recall to include 6 lots of losartan potassium/hydrochlorothiazide tablets due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629693.htm Source: FDA website
Drug Recall 01-22-19
Prinston Pharmaceutical
Prinston Pharmaceutical announced a voluntary recall of irbesartan and irbesartan/hydrochlorothiazide tablets due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629627.htm Source: FDA website
Drug Recall 01-18-19
Evekeo ODT
The Food and Drug Administration (FDA) approved Evekeo ODT™ (amphetamine sulfate orally disintegrating tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric individuals 6 to 17 years of age. Source: FDA website
New Formulation 01-30-19
Gloperba
The Food and Drug Administration (FDA) approved Gloperba® (colchicine oral solution) for the prevention of gout flares in adults. Source: FDA website
New Formulation 01-30-19
Jeuveau
The Food and Drug Administration (FDA) approved Jeuveau™ (prabotulinumtoxinA-xvfs injection) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. Source: FDA website
New Formulation 02-01-19
Cablivi
The Food and Drug Administration (FDA) approved Cablivi® (caplacizumab-yhdp injection) for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP). Source: FDA website
New Drug 02-06-19
Levetiracetam
Dr. Reddy's Laboratories announced a voluntary recall of levetiracetam in 0.54% sodium chloride injection 1500 mg/100 mL due to mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm630542.htm Source: FDA website
Drug Recall 02-04-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) as adjuvant therapy in the treatment of individuals with resected, high-risk stage III melanoma. Source: FDA website
New Indication 02-15-19
Kisqali Femara Co-Pack
The Food and Drug Administration (FDA) approved Kisqali® Femara® Co-Pack (ribociclib/letrozole tablets) as initial endocrine-based therapy for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Source: FDA website
New Indication 02-13-19
Vancomycin
The Food and Drug Administration (FDA) approved premixed Vancomycin injection in a ready-to-use bag approved in adults and pediatric individuals (1 month and older) for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections. Source: FDA website
New Formulation 02-15-19
Egaten
The Food and Drug Administration (FDA) approved Egaten™ (triclabendazole tablets) for the treatment of fascioliasis in individuals 6 years of age and older. Source: FDA website
New Drug 02-13-19
Esperoct
The Food and Drug Administration (FDA) approved Esperoct® (turoctocog alfa pegol injection) for adults and children with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding, Source: FDA website
New Drug 02-19-19
Uloric
The Food and Drug Administration (FDA) concluded there is an increased risk of death with Uloric (febuxostat) compared with another gout medication, allopurinol. This conclusion is based on the review of results from a safety trial that found an increased risk of heart-related death and death from all causes with Uloric. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM631824 Source: FDA website
Drug Warning 02-21-19
Lonsurf
The Food and Drug Administration (FDA) approved Lonsurf® (trifluridine/tipiracil tablets) for the treatment of adults with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. Source: FDA website
New Indication 02-25-19
Soliqua
The Food and Drug Administration (FDA) approved Soliqua® (insulin glargine/lixisenatide injection) for use as an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on oral antidiabetic medications. Source: FDA website
Expanded Indication 02-25-19
Lotemax SM
The Food and Drug Administration (FDA) approved Lotemax®; SM (loteprednol etabonate ophthalmic gel) for the treatment of postoperative inflammation and pain following ocular surgery. Source: FDA website
New Formulation 02-25-19
Herceptin Hylecta
The Food and Drug Administration (FDA) approved Herceptin Hylecta™ (trastuzumab/hyaluronidase subcutaneous injection) for the treatment of human epidermal growth factor receptor 2 (HER2) overexpressing breast cancer. Source: FDA website
New Formulation 02-28-19
Adhansia XR
The Food and Drug Administration (FDA) approved Adhansia XR™ (methylphenidate extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years and older. Source: FDA website
New Formulation 02-27-19
Xeljanz/Xeljanz XR
The Food and Drug Administration (FDA) alerted the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of Xeljanz® (tofacitinib tablets) or Xeljanz XR® (tofacitinib extended-release tablets) was used in individuals with rheumatoid arthritis (RA). This dose is only approved for ulcerative colitis (UC). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632016.htm Source: FDA website
Drug Warning 02-25-19
Drospirenone/ethinyl estradiol
Apotex Corp announced a voluntary recall of 4 lots of drospirenone/ethinyl estradiol tablets for contraception due to the possibility of missing/incorrect tablet arrangement. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632629.htm Source: FDA website
Drug Recall 03-04-19
AurobindoPharma
AurobindoPharma announced an expansion of its voluntary recall to include 38 additional lots of valsartan and amlodipine/valsartan tablets due to unacceptable amounts of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632442.htm Source: FDA website
Drug Recall 03-01-19
Macleods Pharmaceuticals
Macleods Pharmaceuticals Limited announced a voluntary recall of one lot of losartan potassium/hydrochlorothiazide tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm631880.htm Source: FDA website
Drug Recall 02-25-19
Camber Pharmaceuticals
Camber Pharmaceuticals announced a voluntary recall of 87 lots of valsartan tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632395.htm Source: FDA website
Drug Recall 02-28-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals announced a voluntary recall of 60 lots of losartan tablets and 54 lots of losartan/hydrochlorothiazide tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632509.htm Source: FDA website
Drug Recall 03-03-19
Myobloc
The Food and Drug Administration (FDA) approved Myobloc® (rimabotulinumtoxinB injection) for the treatment of adults with chronic sialorrhea. Source: FDA website
New Indication 09-03-19
Ofev
The Food and Drug Administration (FDA) approved Ofev® (nintedanib capsules) to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma. Source: FDA website
New Indication 09-06-19
Tybost
The Food and Drug Administration (FDA) approved Tybost® (cobicistat tablets) for use with atazanavir and other antiretroviral agents in the treatment of human immunodeficiency virus-1 (HIV-1) infection in pediatric individuals weighing 35 kg or more. Source: FDA website
Expanded Indication 08-22-19
Sovaldi
The Food and Drug Administration (FDA) approved Sovaldi® (sofosbuvir tablets) for pediatric individuals 3 years of age and older with genotype 2 or 3 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. Source: FDA website
Expanded Indication 08-28-19
Harvoni
The Food and Drug Administration (FDA) approved Harvoni® (sofosbuvir/ledipasvir tablets) for pediatric individuals 3 years of age and older with genotype 2 or 3 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. Source: FDA website
Expanded Indication 08-28-19
Riomet ER
The Food and Drug Administration (FDA) approved Riomet ER™ (metformin extended-release oral suspension) as an adjunct to diet and exercise to improve glycemic control in adults and pediatric individuals 10 years of age and older with type 2 diabetes mellitus. Source: FDA website
New Formulation 08-29-19
Pacifico National
Pacifico National, doing business as AmEx Pharmacy, announced a voluntary recall of all lots of Bevacizumab injection due to quality and safety concerns. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pacifico-national-inc-dba-amex-pharmacy-issues-voluntary-nationwide-recall-all-lots-bevacizumab Source: FDA website
Drug Recall 08-30-19
Hospira
Hospira announced a voluntary recall of one lot of Bacteriostatic water for injection due to lack of confirmation of sterilization for some vials. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-bacteriostatic-water-injection-usp-due Source: FDA website
Drug Recall 09-06-19
Aczone
The Food and Drug Administration (FDA) approved Aczone® (dapsone topical gel) for treatment of acne vulgaris in individuals aged 9 years and older. Source: FDA website
Expanded Indication 09-12-19
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) for use in children as young as 6 years of age who have severe eosinophilic asthma. Source: FDA website
Expanded Indication 09-12-19
Gvoke
The Food and Drug Administration (FDA) approved Gvoke (glucagon injection) for the treatment of severe hypoglycemia in children and adults aged two years and older with diabetes. Source: FDA website
New Formulation 09-10-19
Ibsrela
The Food and Drug Administration (FDA) approved Ibsrela® (tenapanor tablets) for the treatment of irritable bowel syndrome with constipation in adults. Source: FDA website
New Drug 09-12-19
KRS Global Biotechnology
KRS Global Biotechnology announced a voluntary recall of all lots of unexpired drugs intended to be sterile due to lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/krs-global-biotechnology-inc-issues-voluntary-nationwide-recall-all-human-and-animal-sterile-drug Source: FDA website
Drug Recall 09-13-19
Natpara
Takeda announced a recall for all doses of Natpara injection due to a potential issue related to rubber particulates originating from the Natpara cartridge. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/takeda-issues-us-recall-natparar-parathyroid-hormone-injection-due-potential-rubber-particulate Source: FDA website
Drug Recall 09-05-19
Ibrance, Kisqali, Verzenio
The Food and Drug Administration (FDA) issued a warning that Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib), used to treat advanced breast cancers, may cause rare but severe inflammation of the lungs. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/ibrance-palbociclib-kisqali-ribociclib-and-verzenio-abemaciclib-drug-safety-communication-due-rare Source: FDA website
Drug Warning 09-13-19
Zantac
The Food and Drug Administration (FDA) has reported that some prescription and over-the-counter (OTC) Zantac® (ranitidine oral) medications used for heartburn may contain a nitrosamine impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines Source: FDA website
Drug Warning 09-13-19
Teflaro
The Food and Drug Administration (FDA) approved Teflaro® (ceftaroline fosamil injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric individuals less than 2 months of age. Source: FDA website
Expanded Indication 09-17-19
Erleada
The Food and Drug Administration (FDA) approved Erleada® (apalutamide tablets) for the treatment of individuals with metastatic castration-sensitive prostate cancer (mCSPC). Source: FDA website
Expanded Indication 09-18-19
Delstrigo
The Food and Drug Administration (FDA) approved Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate tablets), as a complete regimen, to include adults with human immunodeficiency virus (HIV)-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro (doravirine) or the individual components of Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate). Source: FDA website
Expanded Indication 09-20-19
Pifeltro
The Food and Drug Administration (FDA) approved Pifeltro™ (doravirine tablets), in combination with other antiretroviral agents, to include adults with human immunodeficiency virus (HIV)-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro (doravirine) or the individual components of Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate). Source: FDA website
Expanded Indication 09-20-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with Lenvima® (lenvatinib capsules) for the treatment of individuals with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. Source: FDA website
New Indication 09-17-19
Ozobax
The Food and Drug Administration (FDA) approved Ozobax™ (baclofen oral solution) for the treatment of spasticity resulting from multiple sclerosis. It may also have value in individuals with spinal cord injuries or diseases. Source: FDA website
New Formulation 09-18-19
Rybelsus
The Food and Drug Administration (FDA) approved Rybelsus® (semaglutide tablets) to control blood sugar in adults with type 2 diabetes along with diet and exercise. Source: FDA website
New Formulation 09-20-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals announced an expansion of its voluntary recall to include 5 additional lots of losartan potassium tablets due to unacceptable amounts of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium-0 Source: FDA website
Drug Recall 09-20-19
Entresto
The Food and Drug Administration (FDA) approved Entresto® (sacubitril/valsartan tablets) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric individuals aged 1 year and older. Source: FDA website
Expanded Indication 10-02-19
Tybost
The Food and Drug Administration (FDA) approved Tybost® (cobicistat tablets) for coadministration with darunavir in pediatric individuals with human immunodeficiency virus-1 (HIV-1) infection weighing at least 40 kg. Source: FDA website
Expanded Indication 10-04-19
Descovy
The Food and Drug Administration (FDA) approved Descovy® (emtricitabine/tenofovir alafenamide tablets) in at-risk adults and adolescents weighing at least 35 kg for human immunodeficiency virus-1 (HIV-1) pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. Source: FDA website
New Indication 10-03-19
Wilate
The Food and Drug Administration (FDA) approved Wilate® (von Willebrand Factor/coagulation Factor VIII complex, human injection) for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes. Source: FDA website
New Indication 10-08-19
Fasenra Pen
The Food and Drug Administration (FDA) approved Fasenra® Pen (benralizumab pre-fillled, single-use, auto-injector) for self-administration as add-on maintenance treatment for severe eosinophilic asthma. Source: FDA website
New Formulation 10-04-19
Hemady
The Food and Drug Administration (FDA) approved Hemady™ (dexamethasone tablets) for use in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. Source: FDA website
New Formulation 10-03-19
Bortezomib
The Food and Drug Administration (FDA) approved Bortezomib injection for the treatment of adults with multiple myeloma and for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. Source: FDA website
New Formulation 10-04-19
Quzyttir
The Food and Drug Administration (FDA) approved Quzyttir™ (cetirizine injection) for the treatment of acute urticaria in adults and children 6 months of age and older. Source: FDA website
New Formulation 10-04-19
Bonsity
The Food and Drug Administration (FDA) approved Bonsity (teriparatide subcutaneous injection) as a follow-on product for Forteo® (teriparatide subcutaneous injection) for the treatment of osteoporosis in individuals at high risk for fractures. Source: FDA website
New Formulation 10-04-19
Scenesse
The Food and Drug Administration (FDA) approved Scenesse® (afamelanotide subcutaneous implant) to increase pain-free light exposure in adults with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria. Source: FDA website
New Drug 10-08-19
Aklief
The Food and Drug Administration (FDA) approved Aklief® (trifarotene cream) for the treatment of acne vulgaris in individuals 9 and older. Source: FDA website
New Drug 10-04-19
Beovu
The Food and Drug Administration (FDA) approved Beovu® (brolocizumab injection) for the treatment of individuals with wet age-related macular degeneration (AMD). Source: FDA website
New Drug 10-08-19
Innoveix Pharmaceuticals
Innoveix Pharmaceuticals announced a voluntary recall of all sterile compounded drug products, within expiry, to the consumer level due to a lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack Source: FDA website
Drug Recall 10-11-19
Lung injury update
The Food and Drug Administration (FDA) warns the public to stop using tetrahydrocannabinol (THC)-containing vaping products and any vaping products obtained off the street due to reports of lung injuries. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/lung-injury-update-fda-warns-public-stop-using-tetrahydrocannabinol-thc-containing-vaping-products Source: FDA website
Drug Warning 10-04-19
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets) to help prevent blood clots for acutely ill individuals without a high risk of bleeding during and after hospitalization. Source: FDA website
Expanded Indication 10-14-19
Xofluza
The Food and Drug Administration (FDA) approved Xofluza™ (baloxavir marboxil tablets) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. Source: FDA website
Expanded Indication 10-16-19
Nplate
The Food and Drug Administration (FDA) approved Nplate® (romiplostim injection) to expand treatment to newly diagnosed adults with immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Source: FDA website
Expanded Indication 10-17-19
Secuado
The Food and Drug Administration (FDA) approved Secuado® (asenapine transdermal system) for the treatment of adults with schizophrenia. Source: FDA website
New Formulation 10-11-19
Reyvow
The Food and Drug Administration (FDA) approved Reyvow™ (lasmiditan tablets) for the acute treatment of migraine with or without aura in adults. Source: FDA website
New Drug 10-11-19
Viatrexx Bio
Viatrexx Bio announced a voluntary recall of 10 mL sterile injectable vials of products due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viatrexx-bio-incorporated-issues-voluntary-nationwide-recall-sterile-injectables-due-lack-sterility Source: FDA website
Drug Recall 10-15-19
Humate-P
CSL Behring is alerting consumers to an error during Humate-P® (antihemophilic factor/von Willebrand factor complex injection) packaging, the potency data was shifted downwards and this may lead to confusion. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/vaccines-blood-biologics/recalls-biologics/important-drug-information-humate-p-antihemophilic-factorvon-willebrand-factor-complex-human?utm_campaign=Untitled%20Email&utm_medium=email&utm_source=Eloqua Source: FDA website
Drug Warning 10-16-19
Ultomiris
The Food and Drug Administration (FDA) approved Ultomiris® (ravulizumab injection) for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adults and pediatric individuals aged one month and older. Source: FDA website
New Indication 10-20-19
Stelara
The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) for the treatment of adults with moderately to severely active ulcerative colitis. Source: FDA website
New Indication 10-21-19
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxina injection) for the treatment of lower limb spasticity in pediatric individuals 2 to 17 years of age, excluding spasticity caused by cerebral palsy. Source: FDA website
New Indication 10-18-19
Baxdela
The Food and Drug Administration (FDA) approved Baxdela® (delafloxacin injection and tablets) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. Source: FDA website
New Indication 10-24-19
Farxiga
The Food and Drug Administration (FDA) approved Farxiga® (dapagliflozin tablets) to reduce the risk of hospitalization for heart failure in individuals with type 2 diabetes and established cardiovascular (CV) disease or multiple CV risk factors. Source: FDA website
Expanded Indication 10-21-19
Xigduo XR
The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin extended-release tablets) to reduce the risk of hospitalization for heart failure in individuals with type 2 diabetes and established cardiovascular (CV) disease or multiple CV risk factors. Source: FDA website
Expanded Indication 10-21-19
Fiasp
The Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes. Source: FDA website
Expanded Indication 10-22-19
Zejula
The Food and Drug Administration (FDA) approved Zejula® (niraparib capsules) for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status. Source: FDA website
Expanded Indication 10-23-19
Amzeeq
The Food and Drug Administration (FDA) approved Amzeeq™ (minocycline topical foam) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric individuals 9 years of age and older. Source: FDA website
New Formulation 10-18-19
Trikafta
The Food and Drug Administration (FDA) approved Trikafta™ (elexacaftor/ivacaftor/tezacaftor tablets) for the treatment of cystic fibrosis (CF) in individuals 12 years and older who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator modulator (CFTR) gene. Source: FDA website
New Drug 10-21-19
Sanofi
Sanofi announced a voluntary recall of all Zantac® (ranitidine oral) over-the-counter (OTC) in the United States due to the potential for detection of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sanofi-provides-update-precautionary-voluntary-recall-zantac-otc-us Source: FDA website
Drug Recall 10-23-19
Dr Reddy's Laboratories
Dr. Reddy’s Laboratories announced a voluntary recall of all its ranitidine medications sold in the United States due to confirmed contamination with N-Nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-confirms-its-voluntary-nationwide-recall-all-ranitidine-products-us-market Source: FDA website
Drug Recall 10-23-19
Perrigo Company
Perrigo Company announced a voluntary recall of all package sizes of ranitidine due to the possible presence of a nitrosamine impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perrigo-company-plc-issues-voluntary-worldwide-recall-ranitidine-due-possible-presence-impurity-n Source: FDA website
Drug Recall 10-23-19
Liletta
The Food and Drug Administration (FDA) approved Liletta® (levonorgestrel-releasing intrauterine system) for the prevention of pregnancy for up to six years. Source: FDA website
Expanded Indication 10/28/2019
Keppra
The Food and Drug Administration (FDA) approved Keppra® (levetiracetam tablets and oral solution) as monotherapy in the treatment of partial-onset seizures in individuals 1 month of age and older. Source: FDA website
Expanded Indication 10/23/2019
Keppra XR
The Food and Drug Administration (FDA) approved Keppra XR® (levetiracetam extended-release tablets) as monotherapy in the treatment of partial-onset seizures in individuals 12 years of age and older. Source: FDA website
Expanded Indication 10/23/2019
Vumerity
The Food and Drug Administration (FDA) approved VumerityTM(diroximel fumarate delayed-release capsules) for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Source: FDA website
New Drug 10/29/2019
Novitium Pharma
Novitium Pharma announced a voluntary recall of all lots within expiry of ranitidine capsules due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novitium-pharma-issues-voluntary-national-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg Source: FDA website
Drug Recall 10/28/2019
Lannett Company
Lannett Company announced a voluntary recall of all lots within expiry of ranitidine syrup 15 mg/mL due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lannett-issues-voluntary-nationwide-recall-ranitidine-syrup-ranitidine-oral-solution-usp-15mgml-due Source: FDA website
Drug Recall 10/25/2019
Alprazolam
Mylan announced a voluntary recall of one lot of alprazolam 0.5 mg tablets due to the presence of a foreign substance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-initiates-voluntary-nationwide-recall-one-lot-alprazolam-tablets-usp-c-iv-05 Source: FDA website
Drug Recall 10/26/2019
Talicia
The Food and Drug Administration (FDA) approved Talicia® (omeprazole magnesium/amoxicillin/rifabutin delayed-release capsules) approved for the treatment of Helicobacter pylori (H. pylori) infection in adults. Source: FDA website
New Formulation 11-04-19
Fluzone High-Dose Quadrivalent
The Food and Drug Administration (FDA) approved Fluzone® High-Dose Quadrivalent (influenza vaccine injection) for use in adults 65 years of age and older to prevent influenza disease caused by influenza A and B strains contained in the vaccine. Source: FDA website
New Formulation 11-04-19
Reblozyl
The Food and Drug Administration (FDA) approved Reblozyl® (luspatercept-aamt injection) for the treatment of anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions. Source: FDA website
New Drug 11-08-19
Fetroja
The Food and Drug Administration (FDA) approved Fetroja® (cefiderocol injection) for the treatment of adults with complicated urinary tract infection (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms, with limited or no alternative treatment options. Source: FDA website
New Drug 11-14-19
Brukinsa
The Food and Drug Administration (FDA) approved Brukinsa™ (zanubrutinib capsules) for the treatment of adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. Source: FDA website
New Drug 11-14-19
American Health Packaging
American Health Packaging announced a voluntary recall of eight lots of ranitidine syrup 150 mg/10 mL due to the detection of trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-issues-voluntary-nationwide-recall-ranitidine-syrup-ranitidine-oral Source: FDA website
Drug Recall 11-08-19
Aurobindo
Aurobindo Pharma announced a voluntary recall of one lot of ranitidine tablets 150 mg and thirty-seven lots of ranitidine capsules 150 mg, ranitidine capsules 300 mg, and ranitidine syrup 150 mg/mL due to the detection of N-nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-38-lots-ranitidine Source: FDA website
Drug Recall 11-08-19
Amneal
Amneal announced a voluntary recall of prescription ranitidine tablets 150 mg and 300 mg due to unacceptable levels of N-nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150mg-and-300mg Source: FDA website
Drug Recall 11-12-19
Lets Gel Kit
Fagron announced a voluntary recall of all unexpired lots of Lets Gel Kit™ (lidocaine hydrochloride/epinephrine bitartrate/tetracaine hydrochloride/sodium metabisulfite/suturagel methylcellulose base/adapter cap/syringes) convenience packs due to potential microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fagron-inc-issues-voluntary-nationwide-recall-lets-gel-kit-convenience-packs-due-potential-microbial Source: FDA website
Drug Recall 11-04-19
MiniMed Pumps
Medtronic announced a recall of specified remote controllers used with MiniMed™ insulin pumps due to potential cybersecurity risks. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-remote-controllers-minimed-insulin-pumps-potential-cybersecurity-risks Source: FDA website
Drug Recall 11-05-19
Biotin
The Food and Drug Administration (FDA) is reminding health care providers and consumers that biotin can significantly interfere with certain lab tests and cause incorrect results. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication Source: FDA website
Drug Warning 11-05-19
Calquence
The Food and Drug Administration (FDA) approved Calquence® (acalabrutinib capsules) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Source: FDA website
New Indication 11-21-19
Toujeo
The Food and Drug Administration (FDA) approved Toujeo® (insulin glargine injection) to include treatment of pediatric individuals aged 6 years or older with diabetes mellitus. Source: FDA website
Expanded Indication 12-02-19
Exservan
The Food and Drug Administration (FDA) approved Exservan™ (riluzole oral film) for the treatment of amyotrophic lateral sclerosis (ALS). Source: FDA website
New Formulation 11-22-19
RediTrex
The Food and Drug Administration (FDA) approved RediTrex™ (methotrexate subcutaneous injection) for the management of individuals with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy. It is also indicated for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy. Source: FDA website
New Formulation 12-02-19
Adakveo
The Food and Drug Administration (FDA) approved Adakveo® (crizanlizumab injection) to reduce the frequency of vaso-occlusive crises in adults and pediatric individuals aged 16 years and older with sickle cell disease. Source: FDA website
New Drug 11-15-19
Oxbryta
The Food and Drug Administration (FDA) approved Oxbryta™ (voxelotor tablets) for adults and pediatric individuals 12 years of age and older with sickle cell disease. Source: FDA website
New Drug 11-25-19
Givlaari
The Food and Drug Administration (FDA) approved Givlaari™ (givosiran subcutaneous injection) for the treatment of adults with acute hepatic porphyria. Source: FDA website
New Drug 11-20-19
Xcopri
The Food and Drug Administration (FDA) approved Xcopri® (cenobamate tablets) for the treatment of partial-onset seizures in adults. Source: FDA website
New Drug 11-21-19
Golden State Medical Supply
Golden State Medical announced a voluntary recall of all lots within expiry of ranitidine capsules 150 mg and 300 mg due to the potential presence of N-nitrosodimethylamine (NDMA) above levels established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-state-medical-supply-inc-issues-voluntary-nationwide-recall-ranitidine-hydrochloride-150mg Source: FDA website
Drug Recall 11-19-19
Precision Dose
Precision Dose announced a voluntary recall of 5 lots of ranitidine oral solution due to potential N-nitrosodimethylamine (NDMA) amounts above levels established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-ranitidine-oral-solution-usp-150-mg10-ml-due Source: FDA website
Drug Recall 11-21-19